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NOT YET RECRUITING
NCT06973330
PHASE2

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

Sponsor: Anhui Provincial Cancer Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma: a Single-arm, Multi-center, Phase II Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07

Completion Date

2027-05-01

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

DRUG

SOX regimen combined with Sintilimab and Apatinib

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).