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

Phase 2

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: Serplulimab; Drug: Trastuzuma; Drug: Chemotherapy

• Registration Number: NCT05975749
• Lead Sponsor: Fudan University

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 surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-08-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-12
• Primary Completion: 2026-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Lower age limit of research subjects 20 years old and upper age limit of 80 years old.
2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
3. R0 gastrectomy with D2 lymphadenectomy
4. Her2+ diagnosed by Immunohistochemistry or FISH
5. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
6. 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

1. Patients with stage I and IV.
2. Unavailable for R0 resection and D2 lymph node dissection.
3. Multiple primary tumors
4. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
5. History of chemotherapy, radiotherapy, immunotherapy or target therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy	Serplulimab	-
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy	Trastuzuma	-
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy	Chemotherapy	-
Adjuvant Chemotherapy only	Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3-year	DFS

Secondary Outcome Measures

Name	Time	Method
Side effects	12 months]	Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder
Overall survival	3-year	OS

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China