Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

NCT ID: NCT06221423

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-05-31

Brief Summary

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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

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Conditions

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Colorectal Cancer Metastatic Colorectal Cancer Refractory Colorectal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fru plus TAS-102

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

Fruquintinib Combined With TAS-102

Intervention Type DRUG

Fruquintinib Combined With TAS-102

Interventions

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Fruquintinib Combined With TAS-102

Fruquintinib Combined With TAS-102

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xu jianmin

Director of Colorectal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianmin Xu

Role: PRINCIPAL_INVESTIGATOR

Department of Colorectal Surgery, Zhongshan Hospital, Fudan University

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Donghao Xu

Role: CONTACT

17621317456

Facility Contacts

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Donghao Xu

Role: primary

17621317456

Other Identifiers

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Fru plus TAS-102 in mCRC

Identifier Type: -

Identifier Source: org_study_id

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