Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

— 2011PTAHCC  

Official title:

A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409499
• Other study ID #: 2011PTAHCC
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: January 2018

Study information

• Verified date: September 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatectomy
• Hepatocellular Carcinoma
• Sorafenib

Intervention

Procedure:
• hepatic resection
palliative hepatectomy followed by sorafenib
• transcatheter hepatic arterial chemoembolization
TACE followed by sorafenib

Drug:
• sorafenib
sorafenib monotherapy, 400mg Bid, continuously

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	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 (OS)	defined as the time from the first treatment to death	anticipate 6-12 months
Secondary	Progression Free Survival (PFS)	defined as the time from the first treatment to the first progression disease is confirmed by radiological methods	anticipate 3-6 months
Secondary	AEs and SAEs	according to CTC AE 3.0	anticipate 6-12 months
Secondary	cost of treatments	to compare costs of different treatments	3 months in average