NCT01906216

Sorafenib Chemoembolization Evaluation Controlled Trial

Sorafenib With or Without Transarterial Chemoembolization (TACE) in Advanced Hepatocellular Carcinoma : A Multicenter, Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the prognostic factors that influence the survival. Data on the efficacy and safety of sorafenib in combination with TACE in patients with advanced HCC are lacking. Because in western countries, advanced HCC is considered as a contraindication for TACE treatment. However, clinical practice patterns differ markedly between Asia and western countries: in Asia TACE is performed in selected advanced HCC patients. We consider sorafenib combined with TACE could achieve better survival benefit than sorafenib alone in selected advanced HCC patients.

Detailed description

PRIMARY OBJECTIVE: To compare the overall survival of selected advanced HCC patients treated with sorafenib combined with TACE with sorafenib alone. SECONDARY OBJECTIVES: 1. To compare the time to progression (TTP, according to mRECIST criteria). 2. To compare the tumor response and disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST1.1), modified Response Evaluation Criteria in Solid Tumors (mRECIST) and European Association of Liver Disease (EASL) criteria. 3. To compare the safety. OTHER OBJECTIVES: 1\. To explore the prognostic value of AFP response after treatment. OUTLINE: This is a multicenter, phase 3, prospective, randomized, controlled trial. Patients are stratified according to 1. ECOG ( 0 vs. 1) 2. Tumor burden 1. single vs. multiple lesions 2. tumor size (\>8cm vs. ≤8cm) 3. vascular invasion (yes vs. no) 4. extrahepatic metastasis (yes vs. no) 3. Alpha fetoprotein(AFP)(≤ 200 ng/mL vs. \> 200 ng/mL) Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening). Patients undergo the first conventional transarterial chemoembolization (TACE) within 3-7 days after the first administration of sorafenib. The conventional TACE consists of an injection containing a mixture of chemotherapeutic agents (doxorubicin) and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads until complete stasis was achieved in the tumor-feeding vessels. Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated "on demand" depending on the radiological response. ARM II: Patients receive two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening). MAINTENANCE THERAPY: Standard follow-up evaluations include contrast-enhanced CT scan and laboratory assessment. Laboratory assessment will be performed every 4 weeks. Radiological follow-up (contrast-enhanced CT scan in liver and chest X-ray) will be performed during week 4 and week 8 after initiation of treatment and thereafter every 8 weeks.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sorafenib	Sorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).
PROCEDURE	TACE	The first treatment of TACE should be completed within 3-7 days after the administration of sorafenib started. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated "on demand" depending on the radiological response.

Timeline

• Start date: 2013-09-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2013-07-24
• Last updated: 2024-08-28

Locations

1 site across 1 country: China