Back to resultsHX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
Primary Purpose
Stomach Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Irinotecan Hydrochloride Injection
HX008
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Cancer
Eligibility Criteria
Inclusion Criteria:
- Understood and signed an informed consent form.
- Age ≥ 18 and ≤ 75 years old, male or female.
- Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
- Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
- Willing to provide tissue for PD-L1 biomarker analysis.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
- Life expectancy ≥ 3 months.
- Has adequate organ function.
- Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.
Exclusion Criteria:
- Has squamous cell or undifferentiated gastric cancer.
- Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
- Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
- Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has uncontrolled ascites, pleural effusion, or pericardial effusion.
- Has active autoimmune disease that has required systemic treatment in past 2 years.
- Has received a major surgery within 4 weeks prior to randomization.
- Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
- Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.
- Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.
- Has any serious and/or uncontrolled disease.
- Has active viral infection.
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- Has participated in other anticancer drug clinical trials within 4 weeks.
- According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Sites / Locations
- Anhui Provincial Cancer HospitalRecruiting
- Anhui Provincial HospitalRecruiting
- The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
- Beijing ChaoYang Hospital, Capital Medical UniversityRecruiting
- Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
- Peking Union Medical College HospitalRecruiting
- Beijing Friendship Hospital, Capital Medical UniversityRecruiting
- Peking University Third HospitalRecruiting
- Peking University Internationale HospitalRecruiting
- Chongqing University Cancer HospitalRecruiting
- Fujian Cancer HospitalRecruiting
- Gansu Wuwei Tumor HospitalRecruiting
- Affiliated Cancer Hospital of Guangzhou Medical University
- Zhongshan People's Hospital
- Peking University Shenzhen HospitalRecruiting
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen CenterRecruiting
- Guangxi Medical University Cancer HospitalRecruiting
- The First Affiliated Hospital, Sun Yat-sen University
- The Fourth Hospital of Hebei Medical UniversityRecruiting
- The First Hospital of Hebei Medical UniversityRecruiting
- Affiliated Hospital of Hebei UniversityRecruiting
- The affiliated Cancer Hospital of Harbin Medical UniversityRecruiting
- Henan Cancer HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- The First Affiliated Hospital of Henan Science&Technology UniversityRecruiting
- Henan Provincial People's HospitalRecruiting
- The Second Xiangya Hospital of Cancer South UniversityRecruiting
- Xiangya Hospital, Central South University
- Hunan Cancer HospitalRecruiting
- The Affiliated People's Hospital of Inner Mongolia Medical UniversityRecruiting
- Changzhou Cancer HospitalRecruiting
- Jiangsu Provincial HospitalRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Zhongda Hospital Southeast Universtiy
- Nantong Tumor HospitalRecruiting
- The Second Affiliated Hospital of Soochow UniversityRecruiting
- Xuzhou Central HospitalRecruiting
- Yangzhou FIrst People's HospitalRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- Jiangxi Cancer HospitalRecruiting
- Jilin Cancer HospitalRecruiting
- The First Hospital of Jilin University
- The First Hospital of China Medical University
- Liaoning Cancer HospitalRecruiting
- General Hospital of Ningxia Medical UniversityRecruiting
- Shandong Provincial HospitalRecruiting
- Shandong Cancer HospitalRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- Yantai Yuhuangding Hospital
- Shanghai General HospitalRecruiting
- Shanghai Sixth People's Hospital
- Shanxi Cancer HospitalRecruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
- Sichuan Cancer HospitalRecruiting
- Tianjin Medical University General HospitalRecruiting
- Hubei Cancer HospitalRecruiting
- The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
- Xinjiang Medical University Cancer Hospital
- Yunnan Cancer Hospital
- The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- Sir Run Run Shaw Hospital, Medical School of Zhejiang UniversityRecruiting
- Zhejiang Cancer HospitalRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HX008 plus Irinotecan
Placebo plus Irinotecan
Arm Description
Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Outcomes
Primary Outcome Measures
Overall Survival (OS) in All Participants
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.
Overall Survival (OS) in Participants With PD-L1 CPS≥1
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.
Secondary Outcome Measures
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Full Information
NCT ID
NCT04486651
First Posted
July 22, 2020
Last Updated
January 26, 2021
Sponsor
Taizhou Hanzhong biomedical co. LTD
1. Study Identification
Unique Protocol Identification Number
NCT04486651
Brief Title
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
Official Title
A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taizhou Hanzhong biomedical co. LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
560 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HX008 plus Irinotecan
Arm Type
Experimental
Arm Description
Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Arm Title
Placebo plus Irinotecan
Arm Type
Placebo Comparator
Arm Description
Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Intervention Type
Drug
Intervention Name(s)
Irinotecan Hydrochloride Injection
Intervention Description
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
Intervention Type
Drug
Intervention Name(s)
HX008
Intervention Description
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as IV infusion on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Overall Survival (OS) in All Participants
Description
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.
Time Frame
Up to approximately 36 months
Title
Overall Survival (OS) in Participants With PD-L1 CPS≥1
Description
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.
Time Frame
Up to approximately 36 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 36 months
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Time Frame
Up to approximately 36 months
Title
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Time Frame
Up to approximately 36 months
Title
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
Time Frame
Up to approximately 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Understood and signed an informed consent form.
Age ≥ 18 and ≤ 75 years old, male or female.
Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
Willing to provide tissue for PD-L1 biomarker analysis.
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
Life expectancy ≥ 3 months.
Has adequate organ function.
Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.
Exclusion Criteria:
Has squamous cell or undifferentiated gastric cancer.
Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has uncontrolled ascites, pleural effusion, or pericardial effusion.
Has active autoimmune disease that has required systemic treatment in past 2 years.
Has received a major surgery within 4 weeks prior to randomization.
Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.
Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.
Has any serious and/or uncontrolled disease.
Has active viral infection.
Has received a live vaccine within 30 days prior to the first dose of trial treatment.
Has participated in other anticancer drug clinical trials within 4 weeks.
According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang, MD
Phone
010-87788113
Email
huangjingwg@163.com
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifu He
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueyin Pan
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhendong Chen
Facility Name
Beijing ChaoYang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyu An
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Huang, MD
Email
huangjingwg@163.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Zhao
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bangwei Cao
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoshan Cao
Facility Name
Peking University Internationale Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102206
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liang
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiqing Chen
Facility Name
Fujian Cancer Hospital
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongbo Lin
Facility Name
Gansu Wuwei Tumor Hospital
City
Wuwei
State/Province
Gansu
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongbo Lin
Facility Name
Affiliated Cancer Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan Jin
Facility Name
Zhongshan People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
528403
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianjun Xiao
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shubin Wang
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunxia Du
Facility Name
Guangxi Medical University Cancer Hospital
City
Naning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihui Liu
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Ye
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengmian Li
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Li
Facility Name
Affiliated Hospital of Hebei University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimin Zang
Facility Name
The affiliated Cancer Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxian Bai
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suxia Luo
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingxia Fan
Facility Name
The First Affiliated Hospital of Henan Science&Technology University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinshuai Wang
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
540003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shundong Cang
Facility Name
The Second Xiangya Hospital of Cancer South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianling Liu
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan Zeng
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianli Yin
Facility Name
The Affiliated People's Hospital of Inner Mongolia Medical University
City
Huhhot
State/Province
Inner Mongolia
ZIP/Postal Code
010000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenping Wen
Facility Name
Changzhou Cancer Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Ling
Facility Name
Jiangsu Provincial Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingjun Zhu
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Yang
Facility Name
Zhongda Hospital Southeast Universtiy
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cailian Wang
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Yang
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiang Zhuang
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Yuan
Facility Name
Yangzhou FIrst People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiandong Tong
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Xiang
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiye Wan
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Liu
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingdong Zhang
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Chen
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weibo Wang
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Liu
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Lv
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Sun
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia Wang
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zan Shen
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wen
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enxiao Li
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Lu
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansheng Zhong
Facility Name
Hubei Cancer Hospital
City
Hubei
State/Province
Wuhan
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinjun Liang
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenran Wang
Facility Name
Xinjiang Medical University Cancer Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Tang
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Bi
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zheng
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqin Lu
Facility Name
Sir Run Run Shaw Hospital, Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Pan
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haijun Zhong
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Huang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
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