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NCT06221423 Clinical Trial

Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:
A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06221423
Other study ID # Fru plus TAS-102 in mCRC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date May 31, 2024

Study information
Verified date January 2024
Source Fudan University
Contact Donghao Xu
Phone 17621317456
Email xdh1225@yeah.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Fruquintinib Combined With TAS-102
Fruquintinib Combined With TAS-102

Locations
Country Name City State
China Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death. 3 years
Primary Overall Survival (OS) OS was defined as the time from fruquintinib administration to death. 3 years
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