TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

NCT ID: NCT04490694

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-08-01

Brief Summary

It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.

Detailed Description

This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

TACE Combined with Lenvatinib

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

Intervention Description：lenvatinib will be administered daily (for patients \<60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

TACE

Intervention Type: PROCEDURE

Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.

Interventions

Lenvatinib

Intervention Description：lenvatinib will be administered daily (for patients \<60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Intervention Type: DRUG

TACE

Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.

Intervention Type: PROCEDURE

Other Intervention Names

Lenvatinib treatment; Transcatheter arterial chemoembolization

Eligibility Criteria

Inclusion Criteria

• 1. Histopathologically or clinically confirmed unresectable hepatocellular carcinoma.

2. Age ≥ 18 years at time of study entry. 3. Child-Pugh scores <7. 4. Performance status (PS) ≤ 2 (ECOG scale). 5. BCLC stage B, some patients in stage C (Vp2-3). 6. The patient and/or his family agreed to join the clinical trial and sign the informed consent form.

Exclusion Criteria

• 1. Have received TACE or other local treatment for liver cancer (except bridged liver transplantation).

2. Main portal vein tumor thrombus or complicated with extrahepatic metastasis. 3. Tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.

4. Have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy.

5. Estimated life expectancy of <3 months. 6. There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil<1.5×109/L, PLT<50×109/L. The INR>2.3.

7. Renal dysfunction：serum creatinine (SCR) >176.8 μmol/L（2 mg/dL）or creatinine clearance rate (Ccr) <30 mL/min.

8. Serious heart, lung, brain or other important organ diseases. 9. Pregnant or lactating women. 10. cannot cooperate with TACE operation and sign informed consent form.

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

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiping Yan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

B2019-151R

Identifier Type: -

Identifier Source: org_study_id