Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serplulimab, Trastuzuma, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Serplulimab
Serplulimab: 4.5mg/Kg on day 1 - Drug Trastuzuma
Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1 - 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
Primary outcome measures
- Disease-free survival [Time frame: 3-year]
Secondary outcome measures (2)
- Overall survival [Time frame: 3-year]
- Side effects [Time frame: 12 months]]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT05975749 · GC-her2