Clinical trial · Observational
a Cohort Study (Gut Microbiota and HCC)
Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
NCT06557213CI-TRIAL-00079869not yet recruitingClinicalTrials.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 analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (8)
- measure
- Objective Progression-Free Survival (PFS)
- timeFrame
- Up to approximately 1 years
- description
- To analyse the Progression-Free Survival (PFS) of patients
- measure
- Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
- timeFrame
- Up to approximately 1 years
- description
- To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients
- measure
- Objective Objective Response Rate (ORR)
- timeFrame
- Up to approximately 1 years
- description
- To exprole the Objective Response Rate (ORR) of patients
- measure
- ObjectiveDuration of Response (DOR)
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 unlimited 2. Diagnosed as HCC through pathological or clinical examination 3. BCLC Phase B or C 4. Previously without systematic treatment 5. Irremovable 6. Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment 7. ≥ 1 measurable lesion (RECIST V1.1) 8. ECOG PS 0-1 9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. Exclusion Criteria: 1. Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period 2. Active, known or suspected autoimmune diseases 3. Known history of primary immunodeficiency 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 5. Pregnant or lactating female patients 6. Uncontrolled concurrent diseases 7. Currently conducting clinical trials for other drugs 8. Other patients deemed unsuitable for inclusion by researchers
References
Publications (0)
Data not yet available
No reference posted for this study.