Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesophageal Junction Adenocarcinoma

Sponsor
Fudan University
Study ID
NCT07515625
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • AFP Gastric or Gastroesophageal Junction Adenocarcinoma
  • Gastric Cancer (GC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab — DRUG
    Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg iv drip，d1, q3w
  • Bevacizumab — DRUG
    7.5mg/kg，iv drip，d1, q3w
  • Oxaliplatin — DRUG
    130mg/m2，iv drip for 2h，d1, q3w
  • Capecitabine — DRUG
    1000mg/m2 twice daily, d1-14, q3w
  • S-1 — DRUG
    40\~60mg Bid，d1\~14, q3w

Study Details

Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck. Combination of sintilimab, bevacizumab and XELOX/SOX for initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX/SOX in initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma.

Key Dates

First listed
Apr 7, 2026
Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sintilimab, bevacizumab and chemotherapy (XELOX/SOX)
    Sintilimab: 200mg, ivdrip, d1, q3w; Bevacizumab:7.5mg/kg，iv drip，d1, q3w; XELOX:Oxaliplatin+ Capecitabine Capecitabine: 1000mg/m2 twice daily, d1-14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\~60mg Bid, d1\~14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w;

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: From first dose to end of study treatment or last tumor assessment prior to conversion surgery or disease progression.Up to 24 weeks. ]

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