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

Sponsor
Fudan University
Study ID
NCT05975749
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    Serplulimab: 4.5mg/Kg on day 1
  • Trastuzuma — DRUG
    Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1
  • Chemotherapy — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Mar 2024
Primary completion
Jan 1, 2026
Completion
Jan 1, 2029

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
  • Active Comparator: Adjuvant Chemotherapy only

Primary Outcome Measure

Disease-free survival [ Time Frame: 3-year ]

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