Fecal transplant for chemotherapy and targeted-therapy gut side effects in advanced gastrointestinal cancer

An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.

This trial will try oral fecal microbiota transplants (FMT) to see if they reduce chemotherapy or targeted-therapy–related gut symptoms in adults with advanced gastrointestinal cancers.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhejiang, Hangzhou)
• Trial ID: NCT07319364 on ClinicalTrials.gov

What this trial studies

This Phase 1, real-world interventional study tests fecal microbiota transplantation (FMT) in adults with stage IV gastrointestinal tumors who developed gastrointestinal side effects during chemotherapy or targeted therapy. Eligible participants who can swallow capsules will receive oral FMT and be followed for safety, tolerability, and changes in gastrointestinal symptoms. The study enrolls patients planned to start their fourth cycle of systemic therapy who experienced GI adverse reactions within the first three cycles. Outcomes will focus on symptom improvement, adverse events, and likely exploratory microbiome measures.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed stage IV gastrointestinal cancers who are planned for their fourth cycle of chemotherapy or targeted therapy, have had GI side effects within the prior three cycles, have ECOG 1–3, can swallow capsules, and have an expected survival of ≥3 months.

Not a fit: Patients without gastrointestinal side effects, with non-gastrointestinal cancers, who cannot swallow capsules, or with life expectancy under three months are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, FMT could reduce chemo-related diarrhea, nausea, or other gut problems and help patients tolerate cancer treatment better.

How similar studies have performed: Modulating the gut microbiome with FMT or probiotics is an emerging approach with some small studies and case reports suggesting benefit for treatment-related GI toxicity, but large definitive trials are still limited.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years, gender not restricted;
2. Estimated survival time ≥ 3 months;
3. Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
4. TNM staging of cancer in patients is Stage IV;
5. Having undergone PD-1 or PD-L1 testing;
6. Planned to receive the 4th cycle of chemotherapy/targeted therapy;
7. Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy;
8. Patients are able and willing to sign the informed consent form and complete follow-up;
9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
10. Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days;
11. Patients are able to swallow capsules without chewing;
12. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
13. Laboratory test results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria:

1. Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
2. Uncontrolled or severe infections;
3. Known history of psychotropic substance abuse, alcoholism, and drug abuse;
4. Patients with severe infections complicated with septicemia or sepsis;
5. Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
6. Patients with active viral infections;
7. Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);
8. Patients with gastrointestinal perforation and/or fistula;
9. Other conditions deemed unsuitable for enrollment by the investigator.

Where this trial is running

Zhejiang, Hangzhou

• The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang, Hangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Da Wang

Conditions: Fecal Microbiota Transplantation, Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-related Side Effects and Adverse Reactions, Drug-Related Side Effects and Adverse Reactions