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

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.

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.

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.