Back to resultsA Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HLX10
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
- The gender is not limited. When ICF is signed, the age is ≥ 18 years and ≤ 70 years old.
- Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.
- Within 4 weeks prior to first dose, determined by the Independent Radiology Review Committee (IRRC) as: ≥ T3 and number of lymph node metastases ≥ 1 and no distant metastasis.
- Prior to enrollment, the attending physician will evaluate to determine the eligibility for a R0 resection for the purpose of radical treatment.
- Have good cardiac function and can be treated with radical resection.
- tumor specimen testing results are PD-L1 positive (CPS ≥5). Subjects must provide the tumor tissues at screening or in the investigated surgery (if any), for PD-L1 expression level assessment.
- Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;
- Expected survival 12 weeks;
- The functions of the vital organs meet requirements.
Exclusion Criteria:
- Existence of other active malignant tumors within 5 years or at the same time.
- Plan to perform or have undergone an organ or bone marrow transplant.
- Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
- Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) < 50%.
- Human immunodeficiency virus (HIV) infection.
- Patients with active tuberculosis.
- Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
- Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
- Have diseases that may increase the risk of participating in the study and using the study medications, or other severe, acute, and chronic diseases and therefore are judged by the investigator to be unsuitable for clinical studies.
Sites / Locations
- Peking University shenzhen hospitalRecruiting
- Affiliated Hospital of Hebei UniversityRecruiting
- Beijing Cancer HospitalRecruiting
- China PLA General HospitalRecruiting
- Peking University International HospitalRecruiting
- Peking University Third HospitalRecruiting
- The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Cangzhou People's HospitalRecruiting
- Anhui Provincial HospitalRecruiting
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- Linyi Cancer HospitalRecruiting
- The Fourth Hospital of Hebei Medical UniversityRecruiting
- Shanxi Provincial People's HospitalRecruiting
- Tianjin Medical University Institute & HospitalRecruiting
- Xingtai People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HLX10
Placebo
Arm Description
HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase
Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.
Outcomes
Primary Outcome Measures
EFS
event-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)
Secondary Outcome Measures
EFS
Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
DFS
Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
pCR rate
Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
5-year OS rate
5-year overall survival (OS) rate
Full Information
NCT ID
NCT04139135
First Posted
October 16, 2019
Last Updated
June 1, 2022
Sponsor
Shanghai Henlius Biotech
1. Study Identification
Unique Protocol Identification Number
NCT04139135
Brief Title
A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
Official Title
A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
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
This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the efficacy of HLX10 combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer.
Subjects will be randomized to the following two arms at 1: 1 ratio:
Arm A (HLX10 arm): HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase;
Arm B (control arm): Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.
Chemotherapy regimen SOX (oxaliplatin + tegafor gimeracil oteracil potassium (S-1)) will be used in the neoadjuvant treatment phase in Arm A and B, and in the adjuvant treatment phase in Arm B.
After randomization, subjects will receive a total of 3 cycles of neoadjuvant treatment with the mentioned treatment regimen.Surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant treatment.All subjects who have completed the surgery will be unblinded after surgery, and adjuvant treatment will be started 3 to 12 weeks after surgery. Subjects randomized to Arm A (HLX10 arm) will continue to receive HLX10 monotherapy for up to 17 cycles (12 months).Subjects in Arm B after surgery (control arm) will continue to use chemotherapy alone (oxaliplatin + S-1) for 5 cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
642 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX10
Arm Type
Experimental
Arm Description
HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.
Intervention Type
Drug
Intervention Name(s)
HLX10
Other Intervention Name(s)
Recombinant humanized anti-PD-1 monoclonal antibody injection
Intervention Description
neoadjuvant treatment phase：HLX10（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：HLX10（4.5mg/kg/3w IV）
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
neoadjuvant treatment phase：placebos（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：SOX
Primary Outcome Measure Information:
Title
EFS
Description
event-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)
Time Frame
from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
Secondary Outcome Measure Information:
Title
EFS
Description
Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
Time Frame
from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 3 years
Title
DFS
Description
Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
Time Frame
from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years
Title
pCR rate
Description
Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
Time Frame
after surgery，an average of 6 months
Title
5-year OS rate
Description
5-year overall survival (OS) rate
Time Frame
OS is the time from randomization to death (of any cause)，assessed up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
The gender is not limited. When ICF is signed, the age is ≥ 18 years and ≤ 70 years old.
Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.
Within 4 weeks prior to first dose, determined by the Independent Radiology Review Committee (IRRC) as: ≥ T3 and number of lymph node metastases ≥ 1 and no distant metastasis.
Prior to enrollment, the attending physician will evaluate to determine the eligibility for a R0 resection for the purpose of radical treatment.
Have good cardiac function and can be treated with radical resection.
tumor specimen testing results are PD-L1 positive (CPS ≥5). Subjects must provide the tumor tissues at screening or in the investigated surgery (if any), for PD-L1 expression level assessment.
Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;
Expected survival 12 weeks;
The functions of the vital organs meet requirements.
Exclusion Criteria:
Existence of other active malignant tumors within 5 years or at the same time.
Plan to perform or have undergone an organ or bone marrow transplant.
Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) < 50%.
Human immunodeficiency virus (HIV) infection.
Patients with active tuberculosis.
Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
Have diseases that may increase the risk of participating in the study and using the study medications, or other severe, acute, and chronic diseases and therefore are judged by the investigator to be unsuitable for clinical studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiafu JI
Phone
010-88140650
Email
jijiafu@hsc.pku.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen
Facility Information:
Facility Name
Peking University shenzhen hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu bin Wang
Phone
13823394076
Email
Wangshubin2013@163.com
First Name & Middle Initial & Last Name & Degree
Shu bin Wang
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimin Zang, MD
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiafu JI
Phone
01088140650
Email
jijiafu@hsc.pku.edu.cn
Facility Name
China PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen, MD
Facility Name
Peking University International Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liang, MD
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoshan Cao, MD
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Congqiao Jiang, MD
Facility Name
Cangzhou People's Hospital
City
Cangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Bo, MD
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqiang Zhu, MD
First Name & Middle Initial & Last Name & Degree
Gang Wang, MD
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoping Sun, MD
Facility Name
Linyi Cancer Hospital
City
Linyi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingxu Sun, MD
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijia Zhuang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Li, MD
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaogang Bi, MD
Facility Name
Tianjin Medical University Institute & Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Ba, MD
Facility Name
Xingtai People's Hospital
City
Xingtai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhibin Huo, MD
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
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