TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— TREAT  

Official title:

TRansarterial ChEmoembolization Plus SorAfenib Versus Transarterial Chemoembolization Alone for Recurrent Intermediate Hepatocellular Carcinoma: A Phase 3, Open Label, Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103398
• Other study ID #: 20190921
• Status: Completed
• Phase: Phase 3
• Start date: October 2, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Sorafenib
• Transarterial Chemoembolization

Intervention

Combination Product:
• TACE+sorafenib
The initial dose of sorafenib is 400mg BID and the drug therapy will last till outcome events happen or the trial ends. TACE will start one day following oral sorafenib. Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

Procedure:
• TACE
Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.	2 years
Secondary	Progression Free Survival	Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.	2 years
Secondary	Time To Progression	Defined as the time from randomization until disease progression.	2 years
Secondary	Objective Response Rate	The ratio of patients with complete response or partial response among all patients.	2 years
Secondary	Disease Control Rate	The ratio of patients with complete response, partial response or stable disease among all patients.	2 years
Secondary	Adverse Events	Grade 3 or severer hematological or non-hematological adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).	2 years
Secondary	Scoring of Quality of Life	Using the third edition of European Organisation for Research and Treatment of Cancer (EORTC) QOL questionnaire (QLQ-C30).	2 years