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

NCT ID: NCT05975749

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2029-01-01

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy

Group Type: EXPERIMENTAL

Serplulimab

Intervention Type: DRUG

Serplulimab: 4.5mg/Kg on day 1

Trastuzuma

Intervention Type: DRUG

Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1

Chemotherapy

Intervention Type: DRUG

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

Adjuvant Chemotherapy only

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

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

Interventions

Serplulimab

Serplulimab: 4.5mg/Kg on day 1

Intervention Type: DRUG

Trastuzuma

Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1

Intervention Type: DRUG

Chemotherapy

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Dazhi Xu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Dazhi Xu, MD,PHD

Role: primary

xudzh@shca.org.cn

021-64175590

Other Identifiers

GC-her2

Identifier Type: -

Identifier Source: org_study_id