RecruitingPhase 3NCT05918094

Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma


Sponsor

Sun Yat-sen University

Enrollment

540 participants

Start Date

Apr 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a modified chemotherapy-plus-immunotherapy regimen (adjusted doses of XELOX chemotherapy combined with the immunotherapy drug sintilimab) works better or is safer than the standard regimen for people with stomach or esophageal junction cancer that cannot be surgically removed or has spread to other parts of the body. **You may be eligible if:** - You are 18–75 years old - You have been diagnosed with advanced or metastatic stomach or esophageal junction cancer (HER2-negative) - You have not received prior chemotherapy or immunotherapy for this cancer (or finished adjuvant therapy at least 6 months ago without relapse) - You are in reasonably good health and able to perform daily activities - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if:** - Your cancer tests positive for HER2 (a specific protein marker) - You have previously received immunotherapy drugs (such as anti-PD-1 or anti-CTLA-4 antibodies) - You have active autoimmune disease requiring ongoing treatment - You have untreated or unstable brain metastases - You have HIV, active hepatitis B, or active hepatitis C - You have had a recent heart attack, severe heart failure, or uncontrolled heart rhythm problems - You have active intestinal obstruction or a history of gastrointestinal perforation in the past 6 months 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGExperimental dose: modified XELOX + sintilimab

The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W.

DRUGStandard dose: standard XELOX + sintilimab

The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W.


Locations(10)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Affliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05918094


Related Trials