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

Metastatic Colorectal Cancer Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT06347198
• Study type: Interventional
• Source: Wuhan Union Hospital, China
• Contact: Hongli Liu, PhD
• Phone: +86-027-85871962
• Email: hongli_liu@hust.edu.cn
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 10, 2024
• Completion date: May 1, 2025