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

NCT07319364 | Recruiting Phase 1

• 1 other identifier: 2025-1390
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Fecal Microbiota Transplantation; Gastrointestinal Neoplasms; Antineoplastic Agents; Drug-Related Side Effects and Adverse Reactions

Outcome Measures

Primary Outcomes (1)

• Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers

  This outcome measure assesses the incidence (grade ≥1 per CTCAE 5.0) and improvement rate (≥1-grade reduction in symptom severity or ≥30% decrease in EORTC QLQ-C30 scores) of chemotherapy/targeted therapy-induced gastrointestinal (GI) symptoms (e.g., nausea, vomiting, diarrhea) in patients with gastrointestinal cancers receiving fecal microbiota transplantation (FMT), as determined by scale scores and adverse event grading at baseline and post-treatment follow-up.

  At 8 weeks post-FMT

Secondary Outcomes (3)

• The incidence and improvement rate of gastrointestinal (GI) symptoms in patients with gastrointestinal cancers

  At 4 weeks post-FMT

• Changes in Gut Microbiota Diversity Indices

  At 4, 8 weeks post-FMT

• Correlation Between Changes in Gut Microbiota Abundance and Improvement of Gastrointestinal Symptoms

  At 8 weeks post-FMT

Other Outcomes (2)

• Comparison of Changes in Serum Tumor Markers, IL-6, IL-8, Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1), CRP, and Neutrophil (NE) Ratio Before and After FMT Combined with Chemotherapy/Targeted Therapy

  At 8 weeks post-FMT

• Comparison of Changes in Blood Lymphocyte Subsets (e.g., B Cells, NK Cells, Monocytes) Before and After FMT Combined with Chemotherapy/Targeted Therapy

  At 8 weeks post-FMT

Study Arms (2)

Control Group

NO INTERVENTION

Patients in the control group continued their original chemotherapy/targeted therapy regimen, with each treatment cycle lasting 3 weeks, for a total of 5 cycles. Treatment efficacy was assessed after every 2 cycles.

Experimental Group

EXPERIMENTAL

Patients in the FMT group received treatment starting from the fourth cycle on top of their existing regimen. They underwent one FMT treatment 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 gut microbiota 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.

Biological: Fecal microbiota transplantation (FMT)

Interventions

Fecal microbiota transplantation (FMT) BIOLOGICAL

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.

Also known as: Chemotherapy, Targeted Therapy

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• Uncontrolled or severe infections;
• Known history of psychotropic substance abuse, alcoholism, and drug abuse;
• Patients with severe infections complicated with septicemia or sepsis;
• Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
• Patients with active viral infections;
• 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);
• Patients with gastrointestinal perforation and/or fistula;
• Other conditions deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, Hangzhou, 310009, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Drug-Related Side Effects and Adverse Reactions

Interventions

Fecal Microbiota Transplantation; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Da Wang

CONTACT

86-0571-87784720; wangda0618@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 6, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)