NCT06740370Recruiting
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 · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 13 Dec 2024
- Start date
- 13 Dec 2024
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06740370
What you commit to
- Study type: Interventional
- Planned participants: 32
- From 13 Dec 2024 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
Other illness
- History of hepatic encephalopathy and gastrointestinal bleeding
Age
- age \< 18 years or \> 75 years;
Other
- recurrent HCC;
- non-ruptured HCC;
- HCC with more than five metastases;
- life expectancy less than 3 months.
Who the study is looking for
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of hemostasis in the enhanced CT scan;
- integrity of the tumor is disrupted and there is hematoma around the liver;
- receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- transarterial artery chemoembolization (TACE) as local therapy;
- classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
- no history of other malignancies.
- life expectancy more than 3 months;
- agreed to participated in this clinical trial;
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qunfang Zhou Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.