FMT Combined With Standard First-Line Therapy in Initially Unresectable Colorectal Cancer

This clinical trial evaluates the efficacy and safety of adding fecal microbiota transplantation (FMT) to first-line standard of care for patients with initially unresectable colorectal cancer (CRC). FMT is an established procedure designed to restore intestinal microbiome homeostasis by transferring processed fecal microbiota from a rigorously screened healthy donor into the patient's gastrointestinal tract. The standard first-line treatment regimen typically consists of chemotherapy, with or without targeted therapy. Approximately 220 patients across 13 participating centers will be randomly assigned to receive either standard therapy alone or standard therapy combined with FMT. The primary endpoint is the objective response rate (ORR). Secondary endpoints include the conversion to resectability rate, progression-free survival (PFS), safety and adverse events, quality of life (QoL), anxiety and depression scales, as well as dynamic changes in the gut microbiome and circulating biomarkers. The ultimate goal of this trial is to determine whether microbiome modulation via FMT can synergistically enhance the antitumor efficacy of standard first-line therapies and mitigate treatment-related toxicities in this patient population.

NCT Number	NCT07509398
Lead Sponsor	Shanghai 10th People's Hospital Collaborators: Wuhan Central Hospital, Shanxi Bethune Hospital, The General Hospital of Eastern Theater Command, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Maoming People's Hospital, PLA Rocket Force Characteristic Medical Center, Southern Medical University, China, Northern Jiangsu People's Hospital, Guangdong Second Provincial General Hospital, China-Japan Union Hospital, Jilin University, The First Hospital of Jilin University
Conditions	Unresectable Colorectal Cancer, Colorectal Cancer (Locally Advanced or Metastatic)
Enrollment	220 participants
Start Date	2026-04
Primary Completion	2027-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-03