TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Lenvatinib; Procedure: TACE

• Registration Number: NCT04490694
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-26
• Study First Posted: 2020-07-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24
• Primary Completion: 2022-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

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

  4. 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.

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

  6. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TACE Combined with Lenvatinib	TACE	-
TACE Combined with Lenvatinib	Lenvatinib	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	the survival time after randomization
Adverse Events	2 years	Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)

Trial Locations

Locations (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.; 🇨🇳 Shanghai, Shanghai, China