Status:
RECRUITING
Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
Lead Sponsor:
Fudan University
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief 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 surg...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Patients with stage I and IV.
- Unavailable for R0 resection and D2 lymph node dissection.
- Multiple primary tumors
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- History of chemotherapy, radiotherapy, immunotherapy or target therapy.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05975749
Start Date
January 1 2023
End Date
January 1 2029
Last Update
March 12 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 2000000