Antineoplastic Agents, Drug-related Side Effects and Adverse Reactions, Fecal Microbiota Transplantation (FMT), Gastrointestinal Neoplasms
Conditions
Keywords
Fecal Microbiota Transplantation, Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-Related Side Effects and Adverse Reactions
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.
Interventions
BIOLOGICALFecal 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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers | At 8 weeks post-FMT | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and improvement rate of gastrointestinal (GI) symptoms in patients with gastrointestinal cancers | At 4 weeks post-FMT | 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. |
| Changes in Gut Microbiota Diversity Indices | At 4, 8 weeks post-FMT | 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. |
| Correlation Between Changes in Gut Microbiota Abundance and Improvement of Gastrointestinal Symptoms | At 8 weeks post-FMT | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | This secondary outcome measure compares changes in serum tumor markers (e.g., CEA, CA19-9), inflammatory factors (IL-6, IL-8, soluble Tumor Necrosis Factor Receptor 1 \[sTNFR1\], CRP), and Neutrophil (NE) Ratio before and after fecal microbiota transplantation (FMT) combined with chemotherapy/targeted therapy in gastrointestinal cancer patients, by detecting serum samples to evaluate the treatment's impact on tumor burden and systemic inflammatory status. |
| 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 | This outcome measure compares changes in the count and proportion of lymphocyte subsets (e.g., B cells, NK cells, monocytes) by detecting blood samples from gastrointestinal cancer patients before and after fecal microbiota transplantation (FMT) combined with chemotherapy/targeted therapy, to evaluate the treatment's regulatory effect on patients' immune function. |
Countries
China
Contacts
Primary ContactDa Wang
Outcome results
None listed