RecruitingPhase 2NCT05975749

Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer

A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection


Sponsor

Fudan University

Enrollment

114 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding serplulimab (an immunotherapy drug) to standard trastuzumab (targeted HER2 therapy) plus chemotherapy after surgery improves outcomes for patients with HER2-positive gastric (stomach) cancer. **You may be eligible if...** - You are 20–80 years old - You have been diagnosed with stage II or III gastric (stomach) cancer that is HER2-positive - You have had surgery removing the tumor with clear margins (R0 resection) and full lymph node removal (D2) - You are in good physical health (ECOG score 0–1) and expected to survive at least 6 months - Your blood counts, liver, and kidney function are within acceptable range **You may NOT be eligible if...** - Your cancer is stage I or stage IV - You have had multiple different primary cancers - You have serious heart or other organ disease that prevents treatment 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

DRUGSerplulimab

Serplulimab: 4.5mg/Kg on day 1

DRUGTrastuzuma

Trastuzuma: 8mg/Kg ( the first cycle),6mg/Kg (the rest of cycles) on day 1

DRUGChemotherapy

Chemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT05975749


Related Trials