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 | Unknown Phase 2

• 1 other identifier: JS001-033-II-GC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 39

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.

Conditions

Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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).

  Up to 12 months

Secondary Outcomes (11)

• Objective response rate (ORR)

  Up to 12 months

• DoR

  Up to 12 months

• DCR

  Up to 12 months

• PFS

  Up to 12 months

• iORR

  Up to 12 months

Other Outcomes (4)

• Incidence of AEs/SAEs as Assessed by CTCAE v5.0

  Up to 12 months

• JS001 anti-drug antibody assessment

  Up to 12 months

• Epidemiological data survey

  Up to 12 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Experimental group:ToripalimabTreatment

Drug: Toripalimab

Interventions

Toripalimab DRUG

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.

Also known as: Tuoyi

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• With pathologically diagnosed squamous cell carcinoma or sarcoma or undifferentiated carcinoma of the stomach or gastroesophageal junction;
• Patients with necrotic lesions, judged by the investigator to have a risk of massive hemorrhage;
• Symptomatic spinal cord compression, or untreated patients expected to have symptoms of spinal cord compression; or for previously diagnosed and treated spinal cord compression, there is no evidence that the disease is clinically stable for ≥4 weeks before the first study drug administration; 1)Patients with asymptomatic spinal cord compression indicated by imaging, which is assessed as stable by specialists, unless treatment for spinal cord compression is not required temporarily;
• Poorly controlled pleural effusion, pericardial effusion or ascites requiring regular drainage;
• Accompanied by severe peritoneal metastasis, mainly manifested as: clinically significant intestinal obstruction; moderate to large amount of ascites; barium enema revealed small intestinal stenosis;
• Poorly controlled tumor-related pain; 1)For patients requiring analgesics, treatment must be on a stable dose prior to study participation; 2)Symptomatic lesions suitable for palliative radiotherapy (e.g., bone metastasis or metastasis resulting in nerve injury) should be treated before enrollment; 3)Prior to enrollment, local treatment of asymptomatic metastatic lesions that may cause functional deficit or intractable pain due to further growth (e.g., current epidural metastases not associated with spinal cord compression) should be considered if appropriate;
• Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) assessment during screening and previous imaging assessment; 1)Patients who have previously received treatment for CNS metastases, shown to be stable for ≥4 weeks by imaging examination during the screening period, and stopped systemic hormone therapy (prednisone or other hormones with equal efficacy at a dose \> 10 mg/day) for ≥4 weeks before the first study drug administration can participate in the study;
• Patients with a history of carcinomatous meningitis;
• Patients with a weight loss of more than 10% within 2 months before signing the informed consent form;
• Patients with other malignant tumors except for gastric cancer (except for cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer with radical treatment, ductal carcinoma in situ with radical treatment) within 5 years before the first study drug administration;
• Within 28 days prior to the first study drug administration, there are other major surgeries except for the diagnosis of gastric cancer, or major surgeries are expected to be performed during the study, unless assessed by researchers and specialists that they have fully recovered from the complications of major surgery;
• Clinically significant underlying medical conditions (e.g., dyspnea, pneumonia, pancreatitis, poorly controlled diabetes, active or poorly controlled infection, drug or alcohol abuse, or psychiatric disorders) that, in the opinion of the investigator, can affect study drug administration and protocol compliance;
• Presence of severe neurological or psychiatric disorders, including dementia and epileptic seizures;
• Have NCI-CTCAE ≥grade 2 peripheral neuropathy;
• Pregnant or lactating female patients;

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (39)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Affiliated Hospital of Hebei University

Baoding, China

NOT YET RECRUITING

Peking University International Hospital

Beijing, China

NOT YET RECRUITING

Sichuan Cancer Hospital

Chengdu, China

NOT YET RECRUITING

The First Hospital of Jilin University

Ch’ang-ch’un, China

NOT YET RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, China

NOT YET RECRUITING

Union Hospital affiliated to Fujian Medical University

Fuzhou, China

NOT YET RECRUITING

Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, China

NOT YET RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

NOT YET RECRUITING

The sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University Medical College

Hangzhou, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, China

NOT YET RECRUITING

Zhejiang University School of Medicine, Sir Run Run Shaw Hospital

Hangzhou, China

NOT YET RECRUITING

Affiliated Tumor Hospital of Harbin Medical University

Harbin, China

NOT YET RECRUITING

Anhui Provincial Hospital

Hefei, China

NOT YET RECRUITING

Second Affiliated Hospital of Anhui Medical University

Hefei, China

NOT YET RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, China

NOT YET RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Hefei, China

NOT YET RECRUITING

Henan Cancer Hospital

Henan, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanhua University

Hengyang, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, China

NOT YET RECRUITING

The first Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

NOT YET RECRUITING

Jiangxi Provincial Cancer Hospital

Nanchang, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University Junhe Li

Nanchang, China

NOT YET RECRUITING

Jiangsu Cancer Hospital

Nanjing, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

NOT YET RECRUITING

Nantong Tumor Hospital

Nantong, China

NOT YET RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, China

NOT YET RECRUITING

Shengjing Hospital of China Medical University

Shenyang, China

NOT YET RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, China

NOT YET RECRUITING

Shanxi Cancer Hospital

Taiyuan, China

NOT YET RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

NOT YET RECRUITING

Xuzhou Central Hospital

Xuzhou, China

NOT YET RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

NOT YET RECRUITING

Zhengzhou Central Hospital

Zhengzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ding xiaohong

CONTACT

86 13602465823; xiaohong_ding@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 26, 2020
• Study Start: September 28, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: October 26, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (39)