Colorectal Cancer, Metastatic Colorectal Cancer, Refractory Colorectal Carcinoma
Conditions
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.
Interventions
DRUGFruquintinib Combined With TAS-102
Fruquintinib Combined With TAS-102
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 3 years | PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death. |
| Overall Survival (OS) | 3 years | OS was defined as the time from fruquintinib administration to death. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJianmin Xu
Department of Colorectal Surgery, Zhongshan Hospital, Fudan University
Outcome results
None listed