Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma

This is a multi-center, prospective, open label phase II study evaluating the safety and efficacy of standard first-line chemotherapy SOX regimen combined with Sintilimab (anti-PD-1 antibody) and Apatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Anhui Provincial Cancer 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 SOX regimen combined with Sintilimab plus Apatinib every 3 weeks(4 cycles) followed by sintilimab+apatinib until disease progression or intolerable adverse reactions or death(up to 24 months).Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.

NCT Number	NCT06973330
Lead Sponsor	Anhui Provincial Cancer Hospital
Conditions	AFP Gastric or Gastroesophageal Junction Adenocarcinoma
Enrollment	40 participants
Start Date	2025-07
Primary Completion	2027-05-01 (estimated)
Study Completion	2027-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-15