NCT05279677

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms Malignant

Interventions

Type	Name	Description
DRUG	Fecal microbiota transplantation plus Sintilimab and Fruquintinib	Microbiota capsules containing 1g gut microbiota, po d1-3 before anti-tumor treatment, total for 8 cycles. Sintilimab 200mg iv, q3w. Fruquintinib 5mg po d1-14, q3w.

Timeline

• Start date: 2022-08-12
• Primary completion: 2023-10-01
• Completion: 2024-04-01
• First posted: 2022-03-15
• Last updated: 2022-08-23

Locations

1 site across 1 country: China