Clinical trial · Interventional
TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma
TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study
- 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)
Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-PD1 Antibody | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lenvatinib | — | UNRESOLVED | — |
| Transcatheter Arterial Chemoembolization | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| PD-1 Inhibitors | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE plus Lenvatinib and PD-1 inhibitor
- description
- TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.
- interventionNames
- Procedure: TACE
- Drug: Lenvatinib
- Drug: PD-1 Inhibitors
Primary outcomes (1)
- measure
- Progression-Free-Survival (PFS)
- timeFrame
- 12 months
- description
- Progression was defined as progressive disease by independent radiologic review
Secondary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
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; 2. presence of hemostasis in the enhanced CT scan; 3. integrity of the tumor is disrupted and there is hematoma around the liver; 4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy; 5. transarterial artery chemoembolization (TACE) as local therapy; 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2; 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. non-ruptured HCC; 3. Lenvatinib and PD-1 inhibitor treated with as second systemic therapy; 4. age \< 18 years or \> 75 years; 5. HCC with more than five metastases; 6. History of hepatic encephalopathy and gastrointestinal bleeding 7. life expectancy less than 3 months.
References
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