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RECRUITING
NCT05975749
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2023-01-01

Completion Date

2029-01-01

Last Updated

2024-03-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Serplulimab

Serplulimab: 4.5mg/Kg on day 1

DRUG

Trastuzuma

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

DRUG

Chemotherapy

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