Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

Phase 4

Completed

• Conditions: Sorafenib; Hepatocellular Carcinoma; Hepatectomy
• Interventions: Procedure: hepatic resection; Procedure: transcatheter hepatic arterial chemoembolization; Drug: sorafenib

• Registration Number: NCT01409499
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and its efficacy is limited. More active treatments were performed in patients with advanced HCC in China, which include radical hepatectomy or TACE. The study is to investigate whether the active treatment will profit survival of patients, and to evaluate the safety.

Detailed Description

This is a prospective non-randomized controlled study. Patients with advanced hepatocellular carcinoma (BCLC C stage) who underwent palliative resection or TACE followed with Sorafenib or treated by sorafenib alone will be included. The patients will be divided to group A (palliative resection plus sorafenib), group B (palliative TACE plus sorafenib), and group C (sorafenib alone). The sample size will be about 200 cases altogether.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Primary Completion: 2017-06
• Study Completion: 2018-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-09
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Male or female patients > 18 years of age.
• Diagnosed to have advanced HCC (BCLC C stage).
• Patients who have a life expectancy of at least 12 weeks.
• Patients whose primary tumor can be resected.

Definition of resectable in this study:

• Tumor number <=2.
• If number of tumors >= 3, then all tumors were located in the same lobe.
• Without tumor invasion of the main trunk of the portal vein, or hepatic duct, or caval vein.
• Hepatocellular carcinoma with histological diagnose or clinical diagnose according to AASLD.
• No major post-operative complication.
• Patients who have an ECOG PS of 0, or 1.
• Cirrhotic status of Child-Pugh class A only.
• The following laboratory parameters:

Platelet count > 60 x 109/L Hemoglobin > 8.5 g/dL Albumin > 3.5 g/dL Total bilirubin < 25μmol/L Alanine transaminase (ALT) and AST < 2.5 x upper limit of normal Serum creatinine <1.5 x the upper limit of normal Prothrombin time (PT)<3 seconds above control.

• Patients who give written informed consent.

Exclusion Criteria

• Previous or concurrent cancer that is distinct in primary site or histology from HCC.
• History of cardiac disease.
• Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
• Known history of human immunodeficiency virus (HIV) infection
• Known Central Nervous System tumors including metastatic brain disease.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• History of organ allograft.
• Known or suspected allergy to the investigational agent or any agent given in association with this trial.
• Pregnant or breast-feeding patients.
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
• Excluded therapies and medications, previous and concomitant: Systemic chemotherapy and target drug other than sorafenib. Antiviral treatment is allowed.
• Radiotherapy except for which done for bone metastases palliatively.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A, surgery	hepatic resection	The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.
B, TACE	transcatheter hepatic arterial chemoembolization	Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.
C, sorafenib	sorafenib	Patients in group C will receive monotherapy of sorafenib.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	anticipate 6-12 months	defined as the time from the first treatment to death

Secondary Outcome Measures

Name	Time	Method
AEs and SAEs	anticipate 6-12 months	according to CTC AE 3.0
Progression Free Survival (PFS)	anticipate 3-6 months	defined as the time from the first treatment to the first progression disease is confirmed by radiological methods
cost of treatments	3 months in average	to compare costs of different treatments

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China