Clinical trial · Interventional
Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)
A Randomized Controlled Trial Evaluating the Effects of Oral Enterobacterial Capsules in Liver Cancer Patients Treated With Tyrosine Kinase Inhibitors (TKIs) in Combination With Immune Checkpoint Inhibitors (ICIs)
NCT06563934CI-TRIAL-00080007not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the additional efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced liver cancer and treated with tyrosine kinase inhibitors (TKIs) combined with immunotherapy.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib + PD-1 monoclonal antibody | Drug | — | UNRESOLVED |
| Oral enterobacterium capsules | Biological | — | UNRESOLVED |
| Oral enterobacterium capsules placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules
- description
- 1. Lenvatinib 8mg (≤60 kg body weight) or 12 mg (\> 60 kg body weight) orally once a day. PD-1 monoclonal antibody 200mg i.v. once every 3 weeks. 2. Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment.
- interventionNames
- Biological: Oral enterobacterium capsules
- Drug: Lenvatinib + PD-1 monoclonal antibody
- type
- PLACEBO_COMPARATOR
- label
- Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placebo
- description
- 1. Lenvatinib 8mg (≤60 kg body weight) or 12 mg (\> 60 kg body weight) orally once a day. PD-1 monoclonal antibody 200mg i.v. once every 3 weeks. 2. Enterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment.
- interventionNames
- Drug: Lenvatinib + PD-1 monoclonal antibody
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. Previous treatment without systemic therapy; 4. Intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors; 5. Child-Pugh Grade A; 6. ≥ 1 measurable lesion (RECIST v1.1) 7. ECOG PS 0-1 Exclusion Criteria: 1. Usage of antibiotics within 2 weeks prior enrollment; 2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants) 3. 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. Those who are currently undergoing clinical trials of other drugs; 7. Other patients who are considered by the investigator to be unsuitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.