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

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

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).

Sponsors & Collaborators

• Wuhan Central Hospital

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• The General Hospital of Eastern Theater Command

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Maoming People's Hospital

  collaborator OTHER

• PLA Rocket Force Characteristic Medical Center

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Northern Jiangsu People's Hospital

  collaborator OTHER

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Shanghai 10th People's Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2027-12-31

Completion

2031-12-31