NCT06347198

Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer

A Single-center Exploratory Clinical Study of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer.

Detailed description

This was a prospective, two-arm, single-center, exploratory phase I study, randomized 2: 1 into an intervention group (Fruquintinib combined with Sintilimab and inulin group) and a control group (Fruquintinib combined with Sintilimab group). Fruquintinib: 4 mg/d, QD po, administered continuously for 2 weeks with a 1-week discontinuation; Sintilimab 200 mg, I.V., D1, administered every 3 weeks; Inulin: 5 g/d, qd po, in the first week, and 10 g/d, bid po, starting in the second week; Combination therapy was administered every 3 weeks as a treatment cycle. Combination therapy was administered until disease progression, death, or intolerable toxicity. The study was divided into 3 phases: a screening phase, a treatment phase, and a follow-up phase. Tumor status was assessed using imaging methods every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during patient treatment) or intolerable toxicity, and tumor treatment and survival status after disease progression were recorded. Safety observations included changes in AE, laboratory test values, vital signs, and electrocardiographic changes.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib: 4 mg/d, qd po, administered continuously for 2 weeks, discontinued for 1 week;
DRUG	Sintilimab	Sintilimab: 200 mg, i.v.gtt.D1, administered every 3 weeks;
DRUG	Inulin	Inulin: 5g/d, qd po in the first week, 10g/d, bid po from the second week onwards.

Timeline

• Start date: 2024-04-10
• Primary completion: 2024-12-01
• Completion: 2025-05-01
• First posted: 2024-04-04
• Last updated: 2024-04-04

Locations

1 site across 1 country: China