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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Second Affiliated Hospital Zhejiang University School of Medicine
  Zhejiang, Hangzhou, China Recruiting

Study contacts

• Study coordinator: Da Wang
• Email: wangda0618@zju.edu.cn
• Phone: 86-0571-87784720

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.