PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer
- Conditions
- Gastric or Esophagogastric Junction Adenocarcinoma
- Interventions
- Biological: JS001/PlaceboBiological: JS001/placebo combine with Postoperative Adjuvant Chemotherapy
- Registration Number
- NCT05180734
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- 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.
- Detailed Description
"This is a multicenter, randomized, double-blind phase III study, plans to recruit 878 patients who received radical gastrectomy (R0, D2 or higher lymphadenectomy) with postoperative pathological stage II (T4aN0M0) or III (the 8th Edition American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual) gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, and the study intends to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.
Patients meeting the inclusion criteria will be 1:1 randomized into JS001-chemotherapy group and placebo-chemotherapy group. The random stratification factors include adjuvant chemotherapeutic regimens (XELOX versus SOX) and tumor anatomical sites (gastric adenocarcinoma versus gastroesophageal junction adenocarcinoma).
The study treatment will be initiated 4-6 weeks after surgery, and the investigator will select XELOX (Oxaliplatin + capecitabine) or SOX (Oxaliplatin + S-1, tegafur, gimeracil and oteracil potassium) as the adjuvant chemotherapeutic regimen given as 3-week cycles for up to 8 cycles based on each patient's condition; JS001/placebo will be given for up to 17 cycles after surgery, until intolerable toxicity, disease recurrence, patient's withdrawal of consent, investigator's judgment that the patient needs to be withdrawn from the study treatment, or death, whichever comes first.
Safety evaluation, including vital signs, ECOG score, physical examination and laboratory examinations, will be performed on a regular basis during the treatment.
This study will end after the main analysis node of DFS and unblinding for analysis are achieved, or 5 years after enrollment of the last patient, whichever comes first. The Sponsor is entitled to terminate the study at any time due to specific reasons (e. g, major safety issues, force majeure, etc.).
Radiological follow-up: tumor response evaluation will be performed once every 12 weeks ±7 days within the first 5 years after randomization, and once per year subsequently, until disease recurrence or death. When symptoms or signs of suspected recurrence/metastasis occur, the radiological evaluation can be performed at any time. Disease recurrence is defined as local recurrence or distant metastases with clear radiological evidence (CT or MRI).
Survival follow-up: it will be performed once every 12 weeks after disease recurrence, until patient's withdrawal of informed consent, loss to follow-up or death, whichever comes first.
Safety follow-up: adverse events will be closely followed up and recorded, until 60 days after the last dose of treatment or the end of study follow-up (death, loss to follow-up, withdrawal of consent form and the end of study), whichever comes first.
"
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 878
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JS001 240mg, Q3W with XELOX regimen or SOX regimen JS001/Placebo JS001 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 JS001/placebo combine with Postoperative Adjuvant Chemotherapy 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.
- Primary Outcome Measures
Name Time Method DFS in the PD-L1-positive population evaluated by the BICR 5 years 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.
- Secondary Outcome Measures
Name Time Method OS in the PD-L1-positive population 5 years To evaluate the OS for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
DFS in the PD-L1-positive population evaluated by the investigator 5 years To evaluate the disease-free survival (DFS) by the investigator 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.
DFS in the ITT population evaluated by the BICR and investigator, respectively 5 years To evaluate the disease-free survival (DFS) by the blind independent central review (BICR) and investigator,respectively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the ITT population.
OS in the ITT population 5 years To evaluate the OS for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the ITT population.
DFS rate at 3 years in the PD-L1-positive population and the ITT population evaluated by the BICR and investigator, respectively 3 years To evaluate the disease-free survival (DFS) rate at 3 years by the BICR and investigator, respevtively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.
DFS rate at 5 years in the PD-L1-positive population and the ITT population evaluated by the BICR and investigator, respectively 5 years To evaluate the disease-free survival (DFS) rate at 5 years by the BICR and investigator, respevtively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.
OS rate at 3 years in the PD-L1-positive population and the ITT population 3 years To evaluate the OS rate at 3 years for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.
OS rate at 5 years in the PD-L1-positive population and the ITT population 5 years To evaluate the OS rate at 5 years for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.
Immunogenicity of toripalimab Up to the 90 days from last dose of toripalimab To evaluate the incidence and titer of anti-drug antibody (ADA) of toripalimab, and further analyze ADA-positive samples for the presence of Neutralising antibodies (Nab).
Blood trough concentration of toripalimab Up to the 90 days from last dose of toripalimab To evaluate the blood trough concentration of toripalimab
Trial Locations
- Locations (71)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
The Peple's Hospital of Chizhou
🇨🇳Chizhou, Anhui, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Peking University People's hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The first affiliated hospital of chongqing medical universit
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Gansu Provincial Cancer Hospital
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Yuebei People's Hospital
🇨🇳Shaoguan, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Gansu Provincial People's Hospital
🇨🇳Lanzhou, Gansu, China
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
The First Affiliated Hospital of Sun yat-sen University
🇨🇳Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Wuwei Cancer Hospital of Gansu Province
🇨🇳Wuwei, Gansu, China
Guandong General Hospital
🇨🇳Guangzhou, Guandong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The first Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guandong, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
Affiliated Cancer Hospital and Institute of Ghuangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
The First Affiliated Hospital of Henan University of science and Technology
🇨🇳Luoyang, Henan, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
The 2ed Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Henan cancer hospital
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Hunan Cancer Hopital
🇨🇳Changsha, Hunan, China
The First Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
Jiangsu cancer hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
The Second People's Hospital of Wuxi
🇨🇳Wuxi, Jiangsu, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Jiangmen Central Hospital
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shangdong, China
The first Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
LiaoNing Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Jinan Central Hospital
🇨🇳Jinan, Shangdong, China
Qinghai University Affiliated Hosptial
🇨🇳Xining, Qinghai, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Qingdao central medical group
🇨🇳Qingdao, Shandong, China
The first affiliated hospital of Zhejiang medical university
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Shandong Provincial Hospital
🇨🇳Jinan, Shangdong, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Tangdu hospital, Air force Military Medical University
🇨🇳Xian, Shanxi, China
Suining Central Hospital
🇨🇳Suining, Sichuan, China
Zhongshan Hospital, Fudan university
🇨🇳Shanghai, Shanghai, China
Xijing hospital, Air force Military Medical University
🇨🇳Xian, Shanxi, China
SiChuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
Cancer Hospital affiliated to Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China