Actively Recruiting

Phase 2
Age: 20Years - 80Years
All Genders
NCT05975749

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

Led by Fudan University · Updated on 2024-03-12

114

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 20 and 80 years
  • Diagnosed with primary adenocarcinoma of gastric cancer staged II or III by pathology
  • Underwent R0 gastrectomy with D2 lymphadenectomy
  • HER-2 positive confirmed by Immunohistochemistry or FISH
  • ECOG performance status of 0 or 1 with expected survival over 6 months
  • Normal blood counts, liver and kidney function, and electrocardiogram (WBC ≥3.5 x 10^9/L, NEU ≥1.2 x 10^9/L, PLT ≥90 x 10^9/L, HGB ≥80 g/L)
Not Eligible

You will not qualify if you...

  • Patients with stage I or IV gastric cancer
  • Not eligible for R0 resection and D2 lymph node dissection
  • Having multiple primary tumors
  • Suffering from serious diseases such as cardiovascular, respiratory, kidney, or liver diseases, or poorly controlled hypertension, diabetes, or mental disorders
  • History of chemotherapy, radiotherapy, immunotherapy, or targeted therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 2000000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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