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
- Conditions
- Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy
- Interventions
- Registration Number
- NCT04603040
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental group Toripalimab Experimental group:ToripalimabTreatment
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Up to 12 months 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).
- Secondary Outcome Measures
Name Time Method IPFS Up to 12 months IPFS is defined as the time from enrollment to the first documentation of disease progression or death from any cause, whichever occurs first;
DCR Up to 12 months DCR is defined as the proportion of patients with best response of CR or PR or stable disease (SD);
iORR Up to 12 months iORR is defined as the proportion of subjects with best response of CR or PR;
iDCR Up to 12 months iDCR is the proportion of patients with best response of CR or PR or SD;
DoR Up to 12 months 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;
PFS Up to 12 months PFS is defined as the time from enrollment to the first documentation of disease progression or death from any cause, whichever occurs first;
iDoR Up to 12 months 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;
Overall survival (OS) Up to 12 months Overall survival (OS), defined as the time from enrollment to death of the patient from any cause.
Objective response rate (ORR) Up to 12 months 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.
PFS rates at 6 and 12 months Up to 12 months 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
OS rates at 9 months and 12 months Up to 12 months defined as the proportion of patients alive at 9 months and 12 months after enrollment.
Trial Locations
- Locations (39)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Zhejiang University School of Medicine, Sir Run Run Shaw Hospital
🇨🇳Hangzhou, China
Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Zhengzhou Central Hospital
🇨🇳Zhengzhou, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, China
Peking University International Hospital
🇨🇳Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Jilin University
🇨🇳Ch'ang-ch'un, China
Sichuan Cancer Hospital
🇨🇳Chengdu, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, China
Union Hospital affiliated to Fujian Medical University
🇨🇳Fuzhou, China
Affiliated Tumor Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
The sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Zhejiang University Medical College
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Affiliated Tumor Hospital of Harbin Medical University
🇨🇳Harbin, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
The First Affiliated Hospital of Nanhua University
🇨🇳Hengyang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Hefei, China
Henan Cancer Hospital
🇨🇳Henan, China
Shandong Cancer Hospital
🇨🇳Jinan, China
Jiangxi Provincial Cancer Hospital
🇨🇳Nanchang, China
The first Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, China
The First Affiliated Hospital of Nanchang University Junhe Li
🇨🇳Nanchang, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, China
Nantong Tumor Hospital
🇨🇳Nantong, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Xinjiang, China
Xuzhou Central Hospital
🇨🇳Xuzhou, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China