Stereotactic Body Radiation Therapy Plus Lenvatinib and Transarterial Chemoembolization for Advanced Primary Hepatocellular Carcinoma: A Phase 3, Multicentric, Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Overall Survival (OS)
Study Overview
Brief Summary
This is a phase 3, multicentri, randomised, open label study. The purpose is to investigate the safety and efficacy of stereotactic body radiation therapy (SBRT) combined with transarterial chemoembolization (TACE) and lenvatinib (LEN) in the treatment of advanced hepatocellular carcinoma with portal vein tumor thrombus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-75 years old;
- •Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;
- •There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus;
- •ECOG score 0-1;
- •Child-Pugh class A;
- •Expected survival time ≥ 3 months;
- •Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal.
Exclusion Criteria
- •Extrahepatic metastases;
- •Previous history of liver or adjacent tissue radiation;
- •Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;
- •There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;
- •Hypersensitivity to intravenous contrast agents;
- •Pregnant or lactating women or subjects with family planning within two years;
- •With HIV, syphilis infection;
- •Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;
- •Allogeneic organ transplant recipients;
- •Severe dysfunction of heart and kidney or other organs;
- •Active severe infection > grade 2 (NCI-CTC version 5);
- •Suffering from mental and psychological diseases may affect informed consent;
- •Unable to take oral medication;
- •Participated in other drug clinical trials within 12 months before enrollment;
- •Active gastric or duodenal ulcers within 3 months before enrollment.
Arms & Interventions
SBRT+TACE+Lenvatinib
Patients in SBRT+TACE+Lenvatinib group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. SBRT will begin within 3 weeks after the first TACE.
Intervention: Lenvatinib (Drug)
SBRT+TACE+Lenvatinib
Patients in SBRT+TACE+Lenvatinib group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. SBRT will begin within 3 weeks after the first TACE.
Intervention: TACE (Procedure)
SBRT+TACE+Lenvatinib
Patients in SBRT+TACE+Lenvatinib group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. SBRT will begin within 3 weeks after the first TACE.
Intervention: SBRT (Radiation)
Lenvatinib
Patients in Lenvatinib group will take oral lenvatinib alone.
Intervention: Lenvatinib (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Up to 2 years
OS is defined as the time from first treatment to death, regardless of disease recurrence.
Secondary Outcomes
- Progression-Free Survival (PFS)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Incidence of Adverse Events (AE)(Up to 2 years)
- Time to Progression （TTP）(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
Investigators
Ming Kuang
Professor
Sun Yat-sen University