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

NCT06973330 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • AFP Gastric or Gastroesophageal Junction Adenocarcinoma

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).

Sponsors & Collaborators

  • Anhui Provincial Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-05-01
Completion
2027-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06973330 on ClinicalTrials.gov