SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)

Phase 3

Not yet recruiting

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Drug: Lenvatinib; Procedure: TACE; Radiation: SBRT

• Registration Number: NCT05718232
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-29
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Study Start: 2023-03
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lenvatinib	Lenvatinib	Patients in Lenvatinib group will take oral lenvatinib alone.
SBRT+TACE+Lenvatinib	TACE	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.
SBRT+TACE+Lenvatinib	SBRT	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.
SBRT+TACE+Lenvatinib	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 2 years	OS is defined as the time from first treatment to death, regardless of disease recurrence.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 2 years	PFS is defined as the time from the first treatment to progression or death.
Disease Control Rate (DCR)	Up to 2 years	DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by mRECIST criteria.
Incidence of Adverse Events (AE)	Up to 2 years	Incidence of AE is defined as the percentage of patients who suffer adverse events from the first treatment to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time to Progression （TTP）	Up to 2 years	TTP is defined as the time from the first treatment to progression.
Objective Response Rate (ORR)	Up to 2 years	ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China