TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma

NCT06740370 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Not applicable

Started

2024-12-13

Last updated

2025-08-14

Condition(s) studied

Hepatocellular CarcinomaTranscatheter Arterial ChemoembolizationAnti-PD1 AntibodyLenvatinib

Investigational drug(s) / intervention(s)

TACELenvatinib →PD-1 Inhibitors →

TACE: TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.

Lenvatinib: (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day

PD-1 Inhibitors: Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Progression-Free-Survival (PFS) — 12 months
Progression was defined as progressive disease by independent radiologic review

Trial sites (1)

Facility	City	Region	Status
Qunfang Zhou	Beijing	None Selected	Recruiting

On this site

📄 Lenvima (lenvatinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740370 on ClinicalTrials.gov ↗ ← All trials in China