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

NCT ID: NCT06740370

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2026-08-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE plus Lenvatinib and PD-1 inhibitor

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

Group Type: EXPERIMENTAL

TACE

Intervention Type: 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.

Lenvatinib

Intervention Type: DRUG

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

PD-1 Inhibitors

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

Lenvatinib

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

Intervention Type: DRUG

PD-1 Inhibitors

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Qunfang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Duan, MD

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

Qunfang Zhou

Beijing, None Selected, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qunfang Zhou, MD

Role: CONTACT

zhouqun988509@163.com

86 19868000115

Mingyu Liu, MD

Role: CONTACT

go1984liu@163.com

15626040233

Facility Contacts

Qunfang Zhou, MD

Role: primary

zhouqun988509@163.com

8619868000115

Feng Duan, MD

Role: backup

duanfeng@vip.sina.com

8613910984586

Other Identifiers

Liver Projiect 14

Identifier Type: -

Identifier Source: org_study_id