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Experimental group:

Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), In a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.

Toripalimab

Ding xiaohong

Ruihua Xu

Feng Wang

Aimin Zang

Jun Liang

Wei Li

Jin Lu

zhenqing Guo

Xiaoyan Lin

Dongping Chen

Dong Ma

Shirong Deng

Yanhong Deng

Yulong Zheng

Haijun Zhong

hongming pan

Yuxian Bai

Yueyin Pan

Zhendong Chen

Kangsheng Gu

Zishu Wang

Zhihong Zhou

Meiling Wen

Zuoxing Niu

Hua Chen

Huiqin Zhang

Junhe Li

Jianwei Lu

Xiaohua Hu

Lei Yang

Wensheng Qiu

Rong Wu

Min Tao

Zhixiang Zhuan

Lu Wen

Xianglin Yuan

Xin Zhao

Mayinuer. Aili

Ai Yuan

Yanru Qin

Shanyonng Yi

This is a single-arm, multicenter, phase 2 study to assess the efficacy and safety of Toripalimab Injection (JS001) in patients with advanced recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines of therapy and are positive for specific markers.

Patients who meet the requirements will be treated with Toripalimab injection 240 mg once every 3 weeks (q3w) until disease progression based on imaging according to RECIST 1.1 criteria judged by the investigator, or intolerable toxicity, or withdrawal of informed consent, or withdrawal of treatment judged by the investigator, or voluntarydiscontinuation of treatment by the patient with CR of more than 6 months, or up to 2 years of treatment for JS001, whichever occurs first.

For the case that the patient shows disease progression on imaging according to RECIST 1.1, as long as the investigator judges that the patient can still benefit from continued medication, the treatment with Toripalimab Injection can be continued until the progression on imaging assessed by the investigator for the second time. The clinical benefit is based on the results of comprehensive assessment by the investigator in combination with imaging findings and clinical condition when the patient has no intolerable toxicity or the symptoms worsen due to disease progression.

Tumor assessments are performed at screening (as the baseline), every 6 weeks from the first dose in the first year, and every 9 weeks from the second year until radiologically documented progressive disease (PD), or second disease progression judged by the investigator (for patients with disease progression shown by first imaging, but who can continue treatment judged by the investigator), or withdrawal of informed consent by the patient, or loss to follow-up, or start of a new anti-tumor therapy, or the termination of the study. If a patient withdraws from the study for reasons other than disease progression (including due to the AE or because the treatment interval is beyond the window) and no disease progression occurs at the time of withdrawal, radiographic assessments should be continued until disease progression, death, or start of a new anti-tumor therapy. Patient medication management is based on the investigator's tumor assessment.

A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers

A Single-arm, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers

Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0

Serum levels of Anti-drug antibody of JS001 treatment

based on the patient data screened by this project, the proportion of PD-L1-positive, EBV-positive, TMB-H and MSI-H patients is assessed

Incidence of Anti-drug antibody of JS001 treatment

ORR assessed by IRC according to RECIST v1.1 assessment criteria. ORR is defined as the proportion of subjects with best response of complete response (CR) or partial response (PR).

ORR assessed by the investigator according to RECIST v1.1 assessment criteria. ORR is defined as the proportion of subjects with best response of CR or PR.

DoR is defined as the time from the first documented response until the first documented evidence of disease progression or death from any cause, whichever occurs first;

DCR is defined as the proportion of patients with best response of CR or PR or stable disease (SD);

PFS is defined as the time from enrollment to the first documentation of disease progression or death from any cause, whichever occurs first;

iORR is defined as the proportion of subjects with best response of CR or PR;

iDoR is the time from the first documented response until the first documented evidence of disease progression or death from any cause, whichever occurs first;

iDCR is the proportion of patients with best response of CR or PR or SD;

IPFS is defined as the time from enrollment to the first documentation of disease progression or death from any cause, whichever occurs first;

Overall survival (OS), defined as the time from enrollment to death of the patient from any cause.

It is defined as the proportion of patients alive without documented disease progression at 6 and 12 months after enrollment assessed by RECIST v1.1 criteria

defined as the proportion of patients alive at 9 months and 12 months after enrollment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers	NCT04603040	Recurrent or Me...	Toripalimab	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers	NCT04603040	Recurrent or Me...	Toripalimab	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers	NCT04603040	Recurrent or Me...	Toripalimab	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy