NCT07509398

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

Efficacy and Safety of Fecal Microbiota Transplantation Combined With First-Line Standard Therapy in Patients With Initially Unresectable Colorectal Cancer: A Multicenter, Open-Label, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Unresectable Colorectal Cancer
• Colorectal Cancer (Locally Advanced or Metastatic)

Interventions

Type	Name	Description
DRUG	Standard First-Line Therapy	Investigator's choice of standard first-line systemic therapy for initially unresectable colorectal cancer, including chemotherapy (e.g., FOLFOX, FOLFIRI, CAPOX) with or without targeted therapy or anti-angiogenic agents (e.g., cetuximab, panitumumab for RAS wild-type; bevacizumab for others), according to CSCO/NCCN guidelines and RAS mutation status.
COMBINATION_PRODUCT	FMT Combined with Standard First-Line Therapy	Fecal microbiota transplantation using donor stool from healthy screened donors. Prepared under P2/GMP conditions as capsules or suspension. Administered in addition to standard therapy per study protocol (induction phase followed by maintenance).

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2031-12-01
• First posted: 2026-04-03
• Last updated: 2026-04-03