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

ConditionsHepatocellular CarcinomaTranscatheter Arterial ChemoembolizationAnti-PD1 AntibodyLenvatinib
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

recurrent HCC;

non-ruptured HCC;

Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;

age < 18 years or > 75 years;

Trial design

Design model

Single group

Treatments tested in this trial

  • TACE

    Procedure/Surgery

    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

    Drug

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

  • PD-1 Inhibitors

    Drug

    Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: TACE plus Lenvatinib and PD-1 inhibitorExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free-Survival (PFS)

Progression was defined as progressive disease by independent radiologic review

Time frame
12 months

Secondary outcomes

1

Objective response rate (ORR)

ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response including complete response or partial response.

Time frame
12 months
2

Overall survival (OS)

OS is the length of time from the date of inclusion until death from any cause.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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