Not Yet RecruitingPhase 2

Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia

66 participantsStarted 2026-05-01

Plain-language summary

This project is a prospective, multicenter, single-arm, phase II clinical study aimed at evaluating the efficacy and safety of fecal microbiota transplantation (FMT) in treating advanced tumor cachexia.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Pre-advanced or advanced tumor cachexia stage.
✓. Age ≥ 18 years old, ECOG score 0-2, expected survival \> 3 months.
✓. Patients with gastric cancer, colorectal cancer, or lung cancer who have received second-line or higher treatment.
✓. No FMT treatment in the past six months.

Exclusion criteria

✕. Any condition that affects gastrointestinal absorption, such as difficulty in swallowing, malabsorption, or uncontrollable vomiting; undergoing tube feeding or parenteral nutrition.
✕. Neurotic anorexia, anorexia caused by mental illness, or difficulty in eating due to pain.
✕. Acquired immunodeficiency syndrome.
✕. Currently taking or planning to take other drugs that increase appetite or weight, such as adrenal corticosteroids (except for short-term use of dexamethasone during chemotherapy), androgens, progestogens, salidroside, olanzapine, and anamorin or other appetite stimulants.
✕. Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with difficult-to-control diabetes.
✕. Current imaging or clinical manifestations of gastrointestinal obstruction.
✕. Current uncontrolled coexisting diseases, including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or mental illnesses/societal conditions that may limit patient compliance with study requirements or affect the patient's ability to provide written informed consent.
✕. Within 12 months prior to the first administration, there was unstable angina pectoris, myocardial infarction, congestive heart failure (grade 2 or above according to the New York Heart Association functional classification), or vascular diseases (such as aneurysms with a risk of rupture), or other cardiac damages that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmias, myocardial ischemia); within 6 months prior to the first administration, there was esophageal-gastric varices, severe ulcers, gastrointestinal perforation and/or fistula history, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess or history of acute gastrointestinal bleeding.

What they're measuring

Fasting weight

Timeframe: Day 0, Day 28, Day 56, Day 84

Trial details

NCT IDNCT07533227

SponsorHua Jiang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Hua Jiang, Prof.

+86 18015852711 czeyjh@njmu.edu.cn

View on ClinicalTrials.gov More Cachexia; Cancer trials