NCT06871527

Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer

Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib/II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

• Gastric (Stomach) Cancer
• Gastric Adenocarcinoma
• Fruquintinib
• PD-1 Inhibitor
• Tislelizumab
• GEJ Adenocarcinoma

Interventions

Type	Name	Description
DRUG	fruquintinib + tislelizumab + FOLFOX	phase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg/d, L2: 4 mg/d, L3: 5 mg/d, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W. phase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin: 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W.

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-03-30
• Completion: 2028-12-31
• First posted: 2025-03-12
• Last updated: 2025-03-12

Locations

1 site across 1 country: China