TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TACE, Lenvatinib, PD-1 Inhibitors.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Anti-PD1 Antibody, Lenvatinib. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study
Overview
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.
Detailed description
Spontaneous rupture of HCC is a life-threatening complication. HCC rupture is considerably higher in China. The tumor size in ruptured HCC is significantly greater than that in non-ruptured HCC. In the acute phase, hemostasis is the first concern and then tumor treatment is secondary. TACE can effectively induce hemostasis. Conservative treatment is usually system therapy for unresectable ruptured HCC. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of TACE combined lenvatinib and PD-1 inhibitor for unresectable ruptured HCC. This study focuses on the efficacy of TACE combined with lenvatinib and PD-1 inhibitor as first-line therapy.
Interventions
- Procedure 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. - Drug Lenvatinib
(12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day - Drug PD-1 Inhibitors
Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)
Primary outcome measures
- Progression-Free-Survival (PFS) [Time frame: 12 months]
Secondary outcome measures (2)
- Objective response rate (ORR) [Time frame: 12 months]
- Overall survival (OS) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- recurrent HCC;
- non-ruptured HCC;
- Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
- age < 18 years or > 75 years;
- HCC with more than five metastases;
- History of hepatic encephalopathy and gastrointestinal bleeding
- life expectancy less than 3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Qunfang Zhou — Beijing
Identifiers
NCT: NCT06740370 · Liver Projiect 14