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

Phase 1RecruitingNCT07319364

Second Affiliated Hospital, School of Medicine, Zhejiang University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: At 8 weeks post-FMT

Secondary Outcomes

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

This outcome measure assesses the incidence (grade ≥1 or exacerbation of baseline symptoms per CTCAE 5.0) and improvement rate (≥1-grade reduction in symptom severity or ≥30% decrease in GSRS scores) of chemotherapy/targeted therapy-induced gastrointestinal symptoms (e.g., nausea, vomiting) in patients with gastrointestinal cancers receiving FMT.

Time frame: At 4 weeks post-FMT

Changes in Gut Microbiota Diversity Indices

This secondary outcome measure assesses changes in gut microbiota α-diversity (Shannon Index and Simpson Index, dimensionless, reflecting microbial richness and evenness) and β-diversity (Bray-Curtis dissimilarity and Jaccard distance, dimensionless, reflecting differences in community structure) after the 4th and 8th cycles of fecal microbiota transplantation (FMT) combined with chemotherapy/targeted therapy in patients with gastrointestinal cancers, using 16S rDNA high-throughput sequencing (V3-V4 region, Illumina NovaSeq platform) to evaluate FMT's regulatory effect on gut microbiota diversity during anti-tumor treatment.

Time frame: At 4, 8 weeks post-FMT

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

This secondary outcome measure explores the correlation between dynamic changes in gut microbiota abundance (relative abundance % at phylum/genus/species levels; absolute abundance of key taxa, copies/μg fecal DNA, detected via 16S rDNA sequencing and qPCR) at baseline, 4th and 8th treatment cycles, and improvement of chemotherapy/targeted therapy-induced GI symptoms (≥30% GSRS score reduction or ≥1-grade CTCAE relief) in gastrointestinal cancer patients receiving FMT + anti-tumor treatment, using Spearman/Pearson coefficients and subgroup analyses by symptom type to reveal the underlying mechanism.