Combining Serplulimab, Trastuzumab, and Chemotherapy for Her-2+ Gastric Cancer
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
This study is testing if combining Serplulimab, Trastuzumab, and chemotherapy can help people with stage II-III Her2+ gastric cancer live longer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Serplulimab, Trastuzumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05975749 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 80 with stage II-III primary adenocarcinoma of gastric cancer who have undergone appropriate surgical resection.
Not a fit: Patients with stage I or IV gastric cancer, or those with multiple primary tumors or serious comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with Her-2+ gastric cancer.
How similar studies have performed: While the combination of targeted therapies and chemotherapy is a common approach, the specific use of Serplulimab with Trastuzumab in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.