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Trial Title:
SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)
NCT ID:
NCT05718232
Condition:
Advanced Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Conditions: Keywords:
SBRT
TACE
Lenvatinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients
<60kg, and 12 mg qd for patients ≥ 60kg)
Arm group label:
Lenvatinib
Arm group label:
SBRT+TACE+Lenvatinib
Intervention type:
Procedure
Intervention name:
TACE
Description:
TACE will be performed one day after oral administration of lenvatinib. Either cTACE or
DEB-TACE can be used, depending on the condition of each center.
Arm group label:
SBRT+TACE+Lenvatinib
Intervention type:
Radiation
Intervention name:
SBRT
Description:
SBRT will be given within 3 weeks after the first TACE with linear accelerator-based
photon beams. Gross tumor volume is defined as intrahepatic tumor and vascular invasion
including a 1-cm margin into the contiguous HCC. Prescription dose will be 4500-5000 cGy
in 5-8 fractions.
Arm group label:
SBRT+TACE+Lenvatinib
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years old;
2. Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the
diagnosis of HCC), without any previous treatment;
3. 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;
4. ECOG score 0-1;
5. Child-Pugh class A;
6. Expected survival time ≥ 3 months;
7. 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:
1. Extrahepatic metastases;
2. Previous history of liver or adjacent tissue radiation;
3. Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal
varices;
4. There are contraindications to TACE treatment, such as portosystemic shunt, liver
flow ablation, significant atherosclerosis;
5. Hypersensitivity to intravenous contrast agents;
6. Pregnant or lactating women or subjects with family planning within two years;
7. With HIV, syphilis infection;
8. Accompanied by other malignant tumors or suffering from other malignancies within 5
years before enrollment;
9. Allogeneic organ transplant recipients;
10. Severe dysfunction of heart and kidney or other organs;
11. Active severe infection > grade 2 (NCI-CTC version 5);
12. Suffering from mental and psychological diseases may affect informed consent;
13. Unable to take oral medication;
14. Participated in other drug clinical trials within 12 months before enrollment;
15. Active gastric or duodenal ulcers within 3 months before enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Contact:
Last name:
Ming Kuang, Ph.D.
Phone:
008687755766
Phone ext:
8576
Email:
kuangm@mail.sysu.edu.cn
Start date:
March 2023
Completion date:
February 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05718232
