TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

NCT04490694 | Unknown Phase 2

• 1 other identifier: B2019-151R
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Transarterial Chemoembolization; lenvatinib

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse Events

  2 years

• Overall survival

  5 years

Study Arms (1)

TACE Combined with Lenvatinib

EXPERIMENTAL

Drug: Lenvatinib; Procedure: TACE

Interventions

Lenvatinib 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.

Also known as: Lenvatinib treatment

TACE Combined with Lenvatinib

TACE 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.

Also known as: Transcatheter arterial chemoembolization

TACE Combined with Lenvatinib

Eligibility Criteria

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

You may qualify if:

• \- 1. Histopathologically or clinically confirmed unresectable hepatocellular carcinoma.
• \. 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.

You may not qualify if:

• \. Have received TACE or other local treatment for liver cancer (except bridged liver transplantation).
• \. 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.
• \. Have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy.
• \. 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.
• \. Renal dysfunction：serum creatinine (SCR) \>176.8 μmol/L（2 mg/dL）or creatinine clearance rate (Ccr) \<30 mL/min.
• \. 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

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

Study Officials

• Zhiping Yan, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 29, 2020
• Study Start: March 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

CN (1)