Combining Serplulimab, Trastuzumab, and Chemotherapy for Her-2+ Gastric Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of Serplulimab in combination with Trastuzumab and chemotherapy for improving survival rates in patients with stage II-III gastric cancer following surgery. The study will enroll patients who have undergone R0 gastrectomy with D2 lymphadenectomy and have a confirmed Her2+ diagnosis. Participants will be monitored for their response to the treatment regimen and overall survival outcomes. The trial focuses on a specific patient population to assess the potential benefits of this novel combination therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.