NCT06094868

Clinical Study of Fruquintinib Combined With Sintilimab and XELOX Regimen in the Treatment of Advanced Cancer

A Single-arm, Open-label, Multicenter Phase II Clinical Study of Fruquintinib Combined With Sintilimab and XELOX in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

Detailed description

To explore the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junctional adenocarcinoma.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib: 4mg, QD, PO, D1-D14, Q3W; Sintilimab: weight \< 60kg, 3mg/kg; weight≥60kg, 200 mg; I.V.， D1，Q3W；. XELOX regimen: Oxaliplatin: 130 mg/m2, ivgtt, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; After 6 cycles of treatment, chemotherapy was given and maintenance treatment was given with Fruquintinib combined with Sintilimab. The above medication regimen can be adjusted according to the adverse reaction tolerance of the subjects. \* Maintenance of treatment until disease progression, or intolerable toxic reactions, or other conditions determined by the investigator

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-10-23
• Last updated: 2023-10-23