Clinical trial · Interventional
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma: A Multicenter, Prospective, Phase II Study
NCT06550921CI-TRIAL-00079756recruitingN/AClinicalTrials.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)
Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ablation | — | UNRESOLVED | — |
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Anti-PD1 Antibody | — | UNRESOLVED | — |
| Lenvatinib | — | UNRESOLVED | — |
| Oligometastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ablation of oligometastasis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ablation-Len-PD-1 inhibitor
- description
- ablation of oligometastasis therapy combined with lenvatinib and PD-1 inhibitor
- interventionNames
- Procedure: ablation of oligometastasis
Primary outcomes (1)
- measure
- Progression-Free-Survival (PFS)
- timeFrame
- 24 months
- description
- Progression-Free-Survival (PFS)
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- 24 months
- description
- OS is the length of time from the date of inclusion until death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20; 2. presence of oligometastasis, the metastases found within three month of HCC diagnosis; 3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm; 4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy for a minimum of 3 months before study ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST); 5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC); 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. no history of other malignancies. 8. life expectancy more than 3 months; 9. agreed to participated in this clinical trial; 10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min. Exclusion Criteria: 1. recurrent HCC; 2. advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy; 3. age \< 18 years or \> 75 years; 4. advanced HCC with more than five metastases; 5. no response to Lenvatinib; 6. metastases size \> 5 cm; 7. life expectancy less than 3 months.
References
Publications (0)
Data not yet available
No reference posted for this study.