Back to resultsPerioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
Primary Purpose
Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib 250mg
Camrelizumab
S-1, Oxaliplatin
Apatinib 500mg
Sponsored by
About this trial
This is an interventional treatment trial for Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
- Plans to proceed to surgery following pre-operative chemotherapy.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Has adequate organ function.
- Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- Has life expectancy of greater than 12 months.
Exclusion Criteria:
- Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- Known hypersensitivity to any of the study drugs or excipients.
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- Congenital or acquired immune deficiency (e.g. HIV infected)
Sites / Locations
- Affiliated Hospital of Hebei UniversityRecruiting
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
- Xiangya Hospital Central South UniversityRecruiting
- Heping Hospital Affiliated to Changzhi Medical CollegeRecruiting
- Sichuan Cancer Hospital & InstituteRecruiting
- Sichuan Provincial People's HospitalRecruiting
- The Affiliated Hospital of Guizhou Medical UniversityRecruiting
- Hainan Cancer HospitalRecruiting
- Cancer Hospital of the University of Chinese Academy of SciencesRecruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
- Hefei Cancer Hospital, Chinese Academy of SciencesRecruiting
- Lanzhou University Second HospitalRecruiting
- Changhai HospitalRecruiting
- Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
- Liaoning Cancer Hospita & InstituteRecruiting
- The Fourth Hospital of Hebei Medical UniversityRecruiting
- Jilin Guowen HospitalRecruiting
- Shanxi Provincial Cancer HospitalRecruiting
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- Tangdu HospitalRecruiting
- Yantai Yuhuangding HospitalRecruiting
- Henan Provincial Cancer HospitalRecruiting
- Affiliated Hospital of Jiangsu UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Apatinib and Camrelizumab and S-1 and Oxaliplatin
Apatinib and S-1 and Oxaliplatin
S-1 and Oxaliplatin
Arm Description
Outcomes
Primary Outcome Measures
Pathological Complete Response (pCR)
Event-free Survival (EFS)
Secondary Outcome Measures
Major pathological response(MPR)
Margin-free (R0) resection rate
DFS
OS
Downstaging of N stage
AEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04208347
Brief Title
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
Official Title
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
580 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apatinib and Camrelizumab and S-1 and Oxaliplatin
Arm Type
Experimental
Arm Title
Apatinib and S-1 and Oxaliplatin
Arm Type
Experimental
Arm Title
S-1 and Oxaliplatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Apatinib 250mg
Intervention Description
Apatinib 250mg
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
Camrelizumab 200mg
Intervention Type
Drug
Intervention Name(s)
S-1, Oxaliplatin
Intervention Description
S-1, Oxaliplatin, q3w
Intervention Type
Drug
Intervention Name(s)
Apatinib 500mg
Intervention Description
Apatinib 500mg
Primary Outcome Measure Information:
Title
Pathological Complete Response (pCR)
Time Frame
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Title
Event-free Survival (EFS)
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Major pathological response(MPR)
Time Frame
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Title
Margin-free (R0) resection rate
Time Frame
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Title
DFS
Time Frame
up to 2 years
Title
OS
Time Frame
up to 3 years
Title
Downstaging of N stage
Time Frame
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Title
AEs
Time Frame
Up to approximately 18 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:
Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
Plans to proceed to surgery following pre-operative chemotherapy.
Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Has adequate organ function.
Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
Has life expectancy of greater than 12 months.
Exclusion Criteria:
Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
Known hypersensitivity to any of the study drugs or excipients.
Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
Congenital or acquired immune deficiency (e.g. HIV infected)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanan Zheng
Phone
+8613636404065
Email
ianzyn@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen LI
Phone
+8613916632699
Email
leedoctor@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenggang Zhu
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiming Zhang
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yantao Tian
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heli Liu
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changhong Lian
Facility Name
Sichuan Cancer Hospital & Institute
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Zhao
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Wang
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Wang
Facility Name
Hainan Cancer Hospital
City
Haikou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Zhao
Facility Name
Cancer Hospital of the University of Chinese Academy of Sciences
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdong Cheng
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Wu
Facility Name
Hefei Cancer Hospital, Chinese Academy of Sciences
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongzhi Wang
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Chen
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Yin
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanan Zheng
Phone
+8613636404065
Facility Name
Liaoning Cancer Hospita & Institute
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhichao Zheng
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Zhao
Facility Name
Jilin Guowen Hospital
City
Siping
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Liang
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhong Dong
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengxue Dang
Facility Name
Tangdu Hospital
City
Xian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Wu
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lixin Jiang
Facility Name
Henan Provincial Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Zhuang
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanrong Xu
12. IPD Sharing Statement
Citations:
PubMed Identifier
33490196
Citation
Zheng Y, Wang Z, Yan C, Yan M, Hou Z, Zheng R, Zhu Z, Li C. Protocol for a randomized controlled trial of perioperative S-1 plus oxaliplatin combined with apatinib and camrelizumab in patients with resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma. Ann Transl Med. 2020 Dec;8(24):1684. doi: 10.21037/atm-20-7802.
Results Reference
derived
PubMed Identifier
32171104
Citation
Zheng Y, Yang X, Yan C, Feng R, Sah BK, Yang Z, Zhu Z, Liu W, Xu W, Ni Z, Beeharry MK, Hua Z, Yan M, Zhu Z, Li C. Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial. Eur J Cancer. 2020 May;130:12-19. doi: 10.1016/j.ejca.2020.02.013. Epub 2020 Mar 11.
Results Reference
derived
Learn more about this trial
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
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