Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
This is a single center, prospective, open label phase I study evaluating the safety and
tolerance of standard first-line chemotherapy XELOX regimen combined with GLS-010 (anti-PD-1
antibody) and different doses of 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. 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 GLS-010 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 GLS-010 (240 mg, intravenous infusion, every 3 weeks) plus
Lenvatinib whose dose is based on the '3 + 3' dose climbing mode (12mg, 16mg and 20mg
respectively, orally once a day). Safety will be evaluated by AE and laboratory tests.
Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Phase:
Phase 1
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital