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

NCT06740370 | Recruiting

• 1 other identifier: Liver Projiect 14
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Transcatheter Arterial Chemoembolization; Anti-PD1 Antibody; Lenvatinib

Keywords

ruptured hepatocellular carcinoma; TACE; Lenvatinib; Tislelizumab; Sintilimab; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

  Progression was defined as progressive disease by independent radiologic review

  12 months

Secondary Outcomes (2)

• Objective response rate (ORR)

  12 months

• Overall survival (OS)

  12 months

Study Arms (1)

TACE plus Lenvatinib and PD-1 inhibitor

EXPERIMENTAL

TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.

Procedure: TACE; Drug: Lenvatinib; Drug: PD-1 Inhibitors

Interventions

TACE PROCEDURE

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.

TACE plus Lenvatinib and PD-1 inhibitor

Lenvatinib DRUG

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

TACE plus Lenvatinib and PD-1 inhibitor

PD-1 Inhibitors DRUG

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

TACE plus Lenvatinib and PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Qunfang Zhou

Beijing, None Selected, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Feng Duan, MD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Mingyu Liu, MD

CONTACT

15626040233; go1984liu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: December 13, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)