TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Lenvatinib

Procedure: TACE

Study type

Interventional

Funder types

Other

Identifiers

NCT04490694

B2019-151R

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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.