TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04490694
• Other study ID #: B2019-151R
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 54
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

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.

Locations

Country	Name	City	State
China	Department of Interventional Radiology, Zhongshan Hospital, Fudan University.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression(TTP)	The time from the beginning of randomization to the tumor progression of the patient	2 years
Primary	Objective remission rate(ORR)	ORR according to modified RECIST for Hepatocellular Carcinoma	2 years
Secondary	Adverse Events	Adverse event (AE)?Treatment emergent adverse event(TEAE)?Serious adverse event (SAE)	2 years
Secondary	Overall survival	the survival time after randomization	5 years