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RECRUITING

NCT07319364

PHASE1

A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-01

Completion Date

2026-09-01

Last Updated

2026-01-06

Healthy Volunteers

Conditions

Fecal Microbiota Transplantation (FMT)Gastrointestinal Neoplasms Antineoplastic Agents Drug-related Side Effects and Adverse Reactions

Interventions

BIOLOGICAL

Fecal microbiota transplantation (FMT)

Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor intestinal bacteria encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.

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.

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, Hangzhou, China