RecruitingNot ApplicableNCT06740370

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


Sponsor

Sun Yat-sen University

Enrollment

32 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at outcomes for patients with ruptured liver cancer (hepatocellular carcinoma that has burst and caused bleeding) who are treated with a combination of tumor-directed embolization (TACE), a targeted drug (lenvatinib), and an immunotherapy drug (PD-1 inhibitor). Ruptured liver cancer is a life-threatening emergency, and this study aims to understand how well this combined approach works after emergency bleeding has been controlled. **You may be eligible if...** - You have a confirmed diagnosis of primary liver cancer (HCC) - Your cancer ruptured but bleeding has been successfully controlled - You are receiving lenvatinib and a PD-1 inhibitor as your first systemic therapy - You are also receiving TACE (a procedure to block blood supply to the tumor) - Your liver function is adequate (Child-Pugh A or B) **You may NOT be eligible if...** - You have previously received other systemic liver cancer treatments - Your liver function is severely impaired - You have not had bleeding controlled before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETACE

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.

DRUGLenvatinib

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

DRUGPD-1 Inhibitors

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


Locations(1)

Qunfang Zhou

Beijing, None Selected, China

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NCT06740370


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