Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy
Trial Parameters
Brief Summary
This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab, Lenvatinib and Paclitaxel in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma after first-line immunotherapy.
Eligibility Criteria
Inclusion Criteria: 1. 18-75 years old, gender is not limited; 2. Histologically or cytologically proven metastatic or locally advanced gastric or gastroesophageal junction adenocarcinoma 3. Programmed death-ligand 1 (PD-L1) positive subjects (CPS ≥ 1), or those who have achieved objective response to first-line Programmed death-1 (PD-1)/PD-L1 inhibitor therapy， or previous first-line PD-1/PD-L1 inhibitor therapy Treatment of PFS ≥ 6 months; 4. Prior chemotherapy, surgery, radiotherapy, or immunotherapy-related toxicity (excluding alopecia) has resolved to CTCAE ≤ grade 1; 5. Has measurable disease as determined by RECIST 1.1； 6. Subjects who can provide tissue samples (preferably freshly obtained tumor tissue before second-line therapy) for central laboratory testing for PD-L1 expression level determination； 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 8. Adequate organ function: 1. Blood routine (no blood transfusion within 14 days before treatment, no gr