NCT05221775

Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

Safety and Efficacy of XELOX Regimen Combined With GLS-010 and Lenvatinib in Patients With Advanced AFP-positive Gastric Cancer: a Single Center, Prospective, Open Label Phase I Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• First-line Treatment
• Advanced Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	XELOX regimen combined with GLS-010 and different doses of Lenvatinib

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-03-01
• Completion: 2023-10-01
• First posted: 2022-02-03
• Last updated: 2022-02-03

Locations

1 site across 1 country: China