Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

ORR

This is a multi-center, prospective, open label phase 2 study evaluating the safety and
 efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab
 (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer.
 This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin
 Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study
 (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with
 promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced
 gastric cancer who had not received palliative systematic treatment in the past will be
 enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined
 with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable
 adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/
 m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with
 Sintilimab (=60kg, 200 mg; 60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus
 Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients
 received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be
 evaluated by AE and laboratory tests.