Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

NCT ID: NCT01409499

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Hepatectomy; Hepatocellular Carcinoma; Sorafenib

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A, surgery

The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.

Group Type: EXPERIMENTAL

hepatic resection

Intervention Type: PROCEDURE

palliative hepatectomy followed by sorafenib

B, TACE

Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.

Group Type: EXPERIMENTAL

transcatheter hepatic arterial chemoembolization

Intervention Type: PROCEDURE

TACE followed by sorafenib

C, sorafenib

Patients in group C will receive monotherapy of sorafenib.

Group Type: EXPERIMENTAL

sorafenib

Intervention Type: DRUG

sorafenib monotherapy, 400mg Bid, continuously

Interventions

hepatic resection

palliative hepatectomy followed by sorafenib

Intervention Type: PROCEDURE

transcatheter hepatic arterial chemoembolization

TACE followed by sorafenib

Intervention Type: PROCEDURE

sorafenib

sorafenib monotherapy, 400mg Bid, continuously

Intervention Type: DRUG

Other Intervention Names

Group A (hepatectomy); Group B (TACE); Group C (sorafenib)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

XU li

Department of Hepatobiliary Surgery, Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minshan Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2011PTAHCC

Identifier Type: -

Identifier Source: org_study_id