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Clinical study on the efficacy and safety of fecal transplantation combined with conventional antitumor therapy for hepatocellular carcinoma

Clinical study on the efficacy and safety of fecal transplantation combined with conventional antitumor therapy for hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061689
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-07-13
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Interventions

case series:none

Sponsors

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Hematological, imaging, cytological or pathological confirmation of hepatocellular carcinoma, including hepatocellular carcinoma, cholangiocarcinoma and hepatoblastoma; 3. Current or previous treatment with first- or second-line targeted agents for hepatocellular carcinoma, including sorafenib, lenvatinib, bevacizumab, regorafenib and apatinib; 4. Expected survival >= 6 months; 5. Efficacy evaluation criteria for solid tumours according to RECIST version 1.1, with at least one evaluable lesion; 6. The patient or legal guardian fully understood the FMT treatment process and mechanism and signed the informed consent for treatment and basic information form, and understood and approved this study.

Exclusion criteria

Exclusion criteria: 1. Unstable vital signs (temperature, heart rate, blood pressure, respiration), severe systemic infections, heart, brain, lung and renal impairment and other related diseases, and vancomycin allergy; 2. Large gastrointestinal ulcers, bleeding or propensity to perforate; 3. Intestinal obstruction of various causes; 4. Those with combined severe malnutrition (body mass index < 15 kg/m2) and severe hypoproteinemia (albumin < 25 g/L); 5. Recent post-operative major surgery and during recovery; 6. Contraindications to the transplant operation itself (transoral diet); 7. Allergy to the ingredients and contents of the capsule; 8. Patients in a state of pregnancy or breastfeeding; 9. Patients with poor compliance who do not accept clinical observation; 10. Other conditions which, in the opinion of the investigator, are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Disease control rate;Overall survival;Progression-free survival;Gut microbes;

Countries

China

Contacts

Public ContactTian Xuefei

Hunan University of Traditional Chinese Medicine

003640@hnucm.edu.cn+86 13787150655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026