Clinical trial NCT04490694: TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
Official title: TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Transarterial Chemoembolization
lenvatinib
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression（TTP）
timeFrame: 2 years
measure: Objective remission rate（ORR）
timeFrame: 2 years
Secondary outcomes:
measure: Adverse Events
timeFrame: 2 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhiping Yan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: