Clinical trial NCT04103398: TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma
Official title: TRansarterial ChEmoembolization Plus SorAfenib Versus Transarterial Chemoembolization Alone for Recurrent Intermediate Hepatocellular Carcinoma: A Phase 3, Open Label, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Sorafenib
Transarterial Chemoembolization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurrent intermediate hepatocellular carcinoma patients.

Detailed description: The trial will recruit 162 patients with recurrent intermediate HCC, and they will be randomized (1:1) into two groups (TACE+sorafenib group, TACE group). Patients in TACE+sorafenib group will receive TACE one day following oral sorafenib (initial dose: 400mg BID). Patients in the TACE group will receive TACE alone.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-75 years;
2. Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
3. Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion \>3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion;
4. Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
5. Eastern Cooperative Oncology Group scoring 0-1;
6. Child-Pugh A class;
7. At least 3 months of life expectancy;
8. Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10\^9/L, platelet ≥ 60 x10\^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT \< 5×ULN, AST \< 5×ULN, alkaline phosphatase \< 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine\<1.5×ULN.

Exclusion Criteria:

1. Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden\>50%;
2. Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;
3. Have contraindications for TACE;
4. Have metastasis in central nervous system;
5. Allergic to intravenous contrast agents;
6. Pregnant or breastfeeding women, or expecting to conceive or father children within two years;
7. Infection of HIV, known syphilis requiring treatment;
8. Have a known history of prior invasive malignancies within 5 years before enrolment;
9. Patients with allotransplantation;
10. Severe dysfunction involving heart, kidney or other organs;
11. Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;
12. Patients with mental disorders which may impact informed consent;
13. Unable to orally take drugs;
14. Participating other clinical drug trials 12 months before enrolment.

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 2 years
measure: Time To Progression
timeFrame: 2 years
measure: Objective Response Rate
timeFrame: 2 years
measure: Disease Control Rate
timeFrame: 2 years
measure: Adverse Events
timeFrame: 2 years
measure: Scoring of Quality of Life
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, PhD
role: STUDY_CHAIR
References: