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

ConditionsUnresectable Colorectal Cancer Colorectal Cancer (Locally Advanced or Metastatic)

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai 10th People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) Subjects must volunteer to participate in this study, sign the informed consent form (ICF), and demonstrate good compliance.

Disqualifiers

(1) Presence of symptoms such as bleeding, perforation, or obstruction at the primary tumor site.

Trial design

Design model

Parallel

Treatments tested in this trial

Standard First-Line Therapy
Drug
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.
FMT Combined with Standard First-Line Therapy
Combination product
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).

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: Standard First-Line TherapyActive comparator 1 intervention

Group B: FMT Combined with Standard First-Line TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Objective Response Rate

Time frame

Up to 12 months (from randomization to best overall response assessment)

Secondary outcomes

Conversion Resection Rate (R0)

Proportion of participants who achieve R0 resection (microscopically negative margins) after conversion therapy, confirmed by pathology. Assessed by multidisciplinary team (MDT) discussion.

Time frame

Up to 12 months

Progression-Free Survival (PFS)

Time from randomization to first documented disease progression (per RECIST 1.1 by BICR) or death from any cause, whichever occurs first.

Time frame

Up to 12 months

Disease Control Rate

Percentage of participants achieving CR, PR, or stable disease (SD) as best overall response per RECIST 1.1 (BICR).

Time frame

Up to 12 months

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence and severity of all AEs and SAEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Includes FMT-related infections and gastrointestinal events.

Time frame

From first dose through 30 days after last dose (up to 12 months)

Other outcomes

Changes in Serum Metabolites

Dynamic changes in core serum metabolites (tryptophan/kynurenine pathway, secondary bile acids, short-chain fatty acids, iron/heme-related metabolites) and their correlation with HADS scores and treatment toxicity.

Time frame

up to 12 months

Changes in Gut Microbiome Composition

Alpha- and beta-diversity changes, abundance shifts in key taxa (Fusobacterium nucleatum, Bacteroides fragilis, Escherichia coli, Candida spp., etc.), and phage proportion changes assessed by metagenomic sequencing.

Time frame

up to 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai 10th People's Hospital

Lead sponsor

Wuhan Central Hospital

Collaborator

Shanxi Bethune Hospital

Collaborator

The General Hospital of Eastern Theater Command

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

Maoming People's Hospital

Collaborator

PLA Rocket Force Characteristic Medical Center

Collaborator

Southern Medical University, China

Collaborator

Northern Jiangsu People's Hospital

Collaborator

Guangdong Second Provincial General Hospital

Collaborator

China-Japan Union Hospital, Jilin University

Collaborator

The First Hospital of Jilin University

Collaborator

Source ClinicalTrials.gov

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