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

Study Overview
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Brief Summary
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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
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Serplulimab
* Drug: Trastuzuma
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy<br> | Drug: Serplulimab<br>* Serplulimab: 4.5mg/Kg on day 1<br>Drug: Trastuzuma<br>* Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1<br>Drug: Chemotherapy<br>* 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<br>|
| Active Comparator: Adjuvant Chemotherapy only<br> | Drug: Chemotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | DFS | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS | 3-year | 
| Side effects | Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder | 12 months] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trastuzuma, Gastric Cancer, Adjuvant treatment, Serplulimab