Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

Recruiting

• Conditions: Refractory Colorectal Carcinoma; Metastatic Colorectal Cancer; Colorectal Cancer
• Interventions: Drug: Fruquintinib Combined With TAS-102

• Registration Number: NCT06221423
• Lead Sponsor: Fudan University

Brief Summary

Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2023-12-27
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-13
• Last Update Submitted: 2024-01-13
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Histology-confirmed metastatic CRC (mCRC)
• Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab
• Fruquintinib administered as salvage treatment
• Age: 18-75 years old
• Informed consent

Exclusion Criteria

• Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy
• Fruquintinib and/or TAS-102 administration as second-line treatment
• Drug administration stopped after less than two cycles

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fru plus TAS-102	Fruquintinib Combined With TAS-102	mCRC patients receiveing Fruquintinib combined with TAS-102 in third- or late- line

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	3 years	PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death.
Overall Survival (OS)	3 years	OS was defined as the time from fruquintinib administration to death.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China