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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975749
• Other study ID #: GC-her2
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Est. completion date: January 1, 2029

Study information

• Verified date: March 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Serplulimab
Serplulimab: 4.5mg/Kg on day 1
• Trastuzuma
Trastuzuma: 8mg/Kg ( the first cycle),6mg/Kg (the rest of cycles) on day 1
• 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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	DFS	3-year
Secondary	Overall survival	OS	3-year
Secondary	Side effects	Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder	12 months]