PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer
A Multicenter, Randomized, Double-Blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Postoperative Adjuvant Chemotherapy Versus Placebo Combined With Postoperative Adjuvant Chemotherapy in Patients With Gastric or Esophagogastric Junction Adenocarcinoma After Radical Gastrectomy
1 other identifier
interventional
878
1 country
71
Brief Summary
This multicenter, randomized, double-blind phase III study intends to recruit about 878 patients, including PD-L1 positive 660 patients, who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage IIB or III (AJCC Cancer Staging Manual, 8th Edition) gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2022
Longer than P75 for phase_3
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
January 15, 2025
January 1, 2025
4.4 years
November 8, 2021
January 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
DFS in the PD-L1-positive population evaluated by the BICR
To evaluate the disease-free survival (DFS) by the blind independent central review (BICR) for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or GEJ adenocarcinoma after radical gastrectomy.
5 years
Secondary Outcomes (10)
OS in the PD-L1-positive population
5 years
DFS in the PD-L1-positive population evaluated by the investigator
5 years
DFS in the ITT population evaluated by the BICR and investigator, respectively
5 years
OS in the ITT population
5 years
DFS rate at 3 years in the PD-L1-positive population and the ITT population evaluated by the BICR and investigator, respectively
3 years
- +5 more secondary outcomes
Study Arms (2)
JS001 240mg, Q3W with XELOX regimen or SOX regimen
EXPERIMENTALJS001 240mg, will be intravenously administered once every 3 weeks, until 17 cycles XELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W. SOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.
Placebo combine with chemotherapy
PLACEBO COMPARATORXELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W. SOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.
Interventions
JS001/placebo combine with Postoperative Adjuvant Chemotherapy
JS001/placebo combine with Postoperative Adjuvant Chemotherapy
Eligibility Criteria
You may qualify if:
- Age 18-75 years.
- No residual tumor (R0) after D2 or greater lymphadenectomy through laparotomy.
- According to the definition of the 8th edition of the AJCC Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology, pathological stage II (T4aN0M0) and stage III, including gastroesophageal junction adenocarcinoma (GEJ) patients.
- Patients need to provide sufficient formalin-fixed paraffin-embedded (FFPE) neoplasm tissue specimens or sections that are confirmed to be PD-L1 positive (CPS ≥ 1) by lab test at the central laboratory.
- ECOG performance status 0-1.
- No metastasis or recurrence as radiologically confirmed.
- Patients must have adequate organ function as assessed in the laboratory tests.
- Patients must provide informed consent for this study, and sign the written informed consent form voluntarily before the initiation of the study, and are willing and able to comply with the scheduled visits, treatment plan, laboratory examinations and other study procedures in the study.
- Female patients of childbearing age must take a serum pregnancy test within 7 days before randomization with negative results, and agree to adopt reliable and effective contraceptive methods during the study.
You may not qualify if:
- Previous use of non-surgical therapy (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric adenocarcinoma.
- Having liver, peritoneal or other distant metastasis.
- Having malignant tumors other than gastric adenocarcinoma within 5 years before randomization.
- Pevious treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) receptor;
- Previous history of serious allergy to monoclonal antibody or other biological preparations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233300, China
The Peple's Hospital of Chizhou
Chizhou, Anhui, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Peking University People's hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Cancer hospital
Beijing, Beijing Municipality, 510515, China
The first affiliated hospital of chongqing medical universit
Chongqing, Chongqing Municipality, 400016, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350011, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
The first Hospital of Lanzhou University
Lanzhou, Gansu, 750050, China
Wuwei Cancer Hospital of Gansu Province
Wuwei, Gansu, 733000, China
Guandong General Hospital
Guangzhou, Guandong, 510000, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guandong, 510280, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
The First Affiliated Hospital of Sun yat-sen University
Guangzhou, Guangdong, 510080, China
Affiliated Cancer Hospital and Institute of Ghuangzhou Medical University
Guangzhou, Guangdong, 510095, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Yuebei People's Hospital
Shaoguan, Guangdong, 512099, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563099, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The 2ed Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 450052, China
Henan cancer hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
Yichang Central People's Hospital
Yichang, Hubei, 443008, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hopital
Changsha, Hunan, 410031, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213004, China
Jiangsu cancer hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226006, China
The Second People's Hospital of Wuxi
Wuxi, Jiangsu, 214001, China
Jiangmen Central Hospital
Nanchang, Jiangxi, 330006, China
The first Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
The First Hospital of China Medical University
Shengyang, Liaoning, 110000, China
LiaoNing Cancer Hospital & Institute
Shenyang, Liaoning, 110000, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000, China
Qinghai University Affiliated Hosptial
Xining, Qinghai, 810000, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Linyi Cancer Hospital
Linyi, Shandong, 276002, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Qingdao central medical group
Qingdao, Shandong, 266042, China
Jinan Central Hospital
Jinan, Shangdong, 250012, China
Shandong Provincial Hospital
Jinan, Shangdong, 250031, China
Affiliated Hospital of Jining Medical University
Jining, Shangdong, 272007, China
Zhongshan Hospital, Fudan university
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012, China
Tangdu hospital, Air force Military Medical University
Xian, Shanxi, 710000, China
Xijing hospital, Air force Military Medical University
Xian, Shanxi, 710000, China
SiChuan Cancer Hospital
Chengdu, Sichuan, 610000, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Cancer Hospital affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The first affiliated hospital of Zhejiang medical university
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325024, China
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
January 6, 2022
Study Start
February 10, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 31, 2028
Last Updated
January 15, 2025
Record last verified: 2025-01