Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

NCT06221423 | Unknown

• 1 other identifier: Fru plus TAS-102 in mCRC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Metastatic Colorectal Cancer; Refractory Colorectal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS)

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

  3 years

• Overall Survival (OS)

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

  3 years

Study Arms (1)

Fru plus TAS-102

mCRC patients receiveing Fruquintinib combined with TAS-102 in third- or late- line

Drug: Fruquintinib Combined With TAS-102

Interventions

Fruquintinib Combined With TAS-102 DRUG

Fruquintinib Combined With TAS-102

Fru plus TAS-102

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory metastatic colorectal cancer who have undergone third-line or later treatment with a combination of fruquintinib and TAS-102.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jianmin Xu

  Department of Colorectal Surgery, Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donghao Xu

CONTACT

17621317456; xdh1225@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Surgery

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 24, 2024
• Study Start: January 1, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CN (1)