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Clinical Trials in China / NCT05975749
Recruiting Phase 2

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

NCT05975749 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2023-01-01
Last updated
2024-03-12

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

SerplulimabTrastuzumaChemotherapy

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

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05975749 on ClinicalTrials.gov ↗ ← All trials in China