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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
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• Lower age limit of research subjects 20 years old and upper age limit of 80 years old.

• Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences

• R0 gastrectomy with D2 lymphadenectomy

• Her2+ diagnosed by Immunohistochemistry or FISH

• ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months

• No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram (WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 114
Treatments
Experimental: Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
Active_comparator: Adjuvant Chemotherapy only
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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