Spots Global Cancer Trial Database for FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of CRC Patients With Advanced Stage
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Trial Identification
Brief Title: FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of CRC Patients With Advanced Stage
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
Study ID: NCT05279677
Conditions
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, , China
Contact Details
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