Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

Fudan University20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer Metastatic Colorectal Cancer Refractory Colorectal Carcinoma

Interventions

Fruquintinib Combined With TAS-102

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death.

Time frame: 3 years

Overall Survival (OS)

OS was defined as the time from fruquintinib administration to death.