RecruitingPhase 3NCT04342910

Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

550 participants

Start Date

Sep 21, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — camrelizumab (an immunotherapy that helps the immune system attack cancer) and apatinib (a drug that cuts off blood supply to tumors) — in patients with advanced stomach or stomach-esophagus junction cancer that has stopped responding to prior chemotherapy. **You may be eligible if:** - You have confirmed stomach cancer or cancer at the junction of the stomach and esophagus - Your cancer has spread or cannot be surgically removed - Your cancer has progressed after at least one round of standard chemotherapy - You are willing to provide a tumor tissue sample for testing - Your cancer has been tested for HER2 status (and if HER2-positive, you have already received trastuzumab) - You are in good general health and your organs are functioning well - Your life expectancy is more than 12 weeks **You may NOT be eligible if:** - Your cancer is a squamous cell or undifferentiated type - You have active brain metastases or cancer spreading to the lining of the brain - You have an active autoimmune disease - You have significant heart or vascular disease - You have uncontrolled high blood pressure - You had serious bleeding in the digestive tract within the past 3 months - You had a stroke, blood clot, or pulmonary embolism in the past 6 months - You have previously received PD-1/PD-L1 immunotherapy or anti-VEGFR drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcamrelizumab

200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.

DRUGApatinib Mesylate

250 mg qd

DRUGPaclitaxel

80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

DRUGIrinotecan

180 mg/m\^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.


Locations(1)

Affiliated Hospital, Academy of Military Medical Sciences

Beijing, China

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NCT04342910


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