Clinical trial · Interventional
Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
A Phase 2, Single-Arm Study of Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
NCT06563947CI-TRIAL-00080012recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
This prospective, single-center, single-arm phase 2 study evaluates the efficacy and safety of adding oral fecal microbiota transplantation (FMT) capsules to continued immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) therapy in adults with advanced hepatocellular carcinoma (HCC) whose disease has progressed during ICI-TKI therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral fecal microbiota transplantation capsules | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy
- description
- Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules (300 mg per capsule) at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.
- interventionNames
- Biological: Oral fecal microbiota transplantation capsules
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year
- description
- Time from the first dose of FMT capsules to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C; 3. Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment; 4. Not suitable for local ablation or chemoembolization; 5. Child-Pugh class A or B, with a score of ≤7; 6. ≥ 1 measurable lesion (RECIST v1.1) 7. ECOG PS 0-2 Exclusion Criteria: 1. Use of antibiotics within 4 weeks prior enrollment; 2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants) 3. Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 4. Female patients who are pregnant or breastfeeding; 5. Patients with untreated acute or chronic active hepatitis B or hepatitis C infection. 6. Patients are currently undergoing clinical trials of other drugs; 7. Patients are considered by the investigator to be unsuitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.