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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Transcatheter Arterial Chemoembolization; Anti-PD1 Antibody; Lenvatinib
• Interventions: Procedure: TACE; Drug: Lenvatinib; Drug: PD-1 Inhibitors

• Registration Number: NCT06740370
• Lead Sponsor: Sun Yat-sen University

Brief 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.

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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-13
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-12-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TACE plus Lenvatinib and PD-1 inhibitor	PD-1 Inhibitors	TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.
TACE plus Lenvatinib and PD-1 inhibitor	TACE	TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.
TACE plus Lenvatinib and PD-1 inhibitor	Lenvatinib	TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	12 months	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.
Overall survival (OS)	12 months	OS is the length of time from the date of inclusion until death from any cause.

Trial Locations

Locations (1)

Qunfang Zhou; 🇨🇳 Beijing, None Selected, China