NCT07515625

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

Conversion Therapy of Sintilimab Combined With Bevacizumab and XELOX/SOX for Initially Unresectable AFP-positive Gastric/Esophagogastric Junction Adenocarcinoma : A Multi-center, Single-arm, Phase II Trial (SOLIDS-02)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2026-04-07
• Last updated: 2026-04-07