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FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of CRC Patients With Advanced Stage

Colorectal Neoplasms Malignant Clinical Trial

Official title:
Phase II, Single-arm Study of FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of Colorectal Cancer Patients With Advanced Stage

Clinical Trial Summary

A single-arm, phase II study was designed to evaluate the efficacy and safety of fecal microbiota transplantation plus Sintilimab and Fruquintinib as the later line treatment in colorectal patients with advanced stages.

Clinical Trial Description

The combination of regorafenib plus nivolumab had already presented a manageable safety profile and encouraging antitumor activity in patients with mCRC as the REGONIVO trail reported. While additional investigations showed limited ORRs between 7%-33% as third or later line treatement in mCRC. Gut microbiota modulation, with the aim to reverse established microbial dysbiosis, is a novel strategy for the treatment of CRC. The individualized gut microbiome transplantation may further imrpove the efficacy of the combination therapy of CPI and TKI. Thus, a single-arm, phase II study was designed to evaluate the efficacy and safety of FMT plus Sintilimab and Fruquintinib as the later line treatment in CRC patients with advanced stages. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05279677
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact Aiping Zhou, MD
Phone 86 13691161998
Email zhouap1825@126.com
Status Recruiting
Phase Phase 2
Start date August 12, 2022
Completion date April 2024
View Details
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