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NCT Number: NCT06221423

Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

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.

Why the study stopped: The study was withdrawn before participant enrollment because the research team decided not to initiate the study after reassessing its feasibility.
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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Colorectal Cancer Neoplasms Neoplasms by Site Rectal Diseases Refractory Colorectal Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruquintinib Combined With TAS-102

Drug

Fruquintinib Combined With TAS-102

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: 3 years

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

  2. Overall Survival (OS)

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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