NCT05177068

Conversion Therapy of Fruquintinib in Combination With Sintilimab and SOX in Unresectable Gastric Cancer

A Phase II Clinical Study of Fruquintinib Combined With Sintilimab and SOX as Conversion Therapy of Potentially Resectable Stage IV Gastric Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to evaluate the efficacy and safety of combination of fruquintinib (VEGFR 1/2/3 inhibitor), sintilimab (PD-1 inhibitor) and SOX conversion therapy in unresectable advanced gastric cancer patients.

Detailed description

Eligible patients will be given 3 or 6 cycles of combined therapy of fruquintinib + sintilimab + SOX. Then the patients evaluated resectable will be given one additional cycle of combined treatment with sintilimab + SOX, followed by R0 resection. If evaluated unresectable after 6 cycles of combination therapy, the patient will be given palliative first-line treatment. Adjuvant treatment with SOX regimen will be started 4 weeks after R0 resection for a total of 8 cycles in the perioperative period.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	fruquintinib + sintilimab + SOX	fruquintinib: 4mg/d, qd po, d1-14, q3w; sintilimab: 200 mg/d, IV d1, q3w; S-1: BSA\<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w; oxaliplatin: 130mg/m2, ivgtt 2-6h, d1, q3w

Timeline

• Start date: 2022-05-13
• Primary completion: 2024-10-16
• Completion: 2025-12-31
• First posted: 2022-01-04
• Last updated: 2025-10-02

Locations

1 site across 1 country: China