TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Lenvatinib; Procedure: TACE

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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TACE Combined with Lenvatinib

Drug: 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.; Other Names: Lenvatinib treatment; Procedure: 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.; Other Names: Transcatheter arterial chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression（TTP）	The time from the beginning of randomization to the tumor progression of the patient	2 years
Objective remission rate（ORR）	ORR according to modified RECIST for Hepatocellular Carcinoma	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)	2 years
Overall survival	the survival time after randomization	5 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Zhiping Yan, M.D., Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; lenvatinib; Transarterial Chemoembolization
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: B2019-151R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No