Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

NCT01409499 | Completed Phase 4 DMC

• 1 other identifier: 2011PTAHCC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatectomy; Hepatocellular Carcinoma; Sorafenib

Keywords

hepatocellular carcinoma, treatments, survival

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  defined as the time from the first treatment to death

  anticipate 6-12 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  anticipate 3-6 months

• AEs and SAEs

  anticipate 6-12 months

• cost of treatments

  3 months in average

Study Arms (3)

A, surgery

EXPERIMENTAL

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

Procedure: hepatic resection

B, TACE

EXPERIMENTAL

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

Procedure: transcatheter hepatic arterial chemoembolization

C, sorafenib

EXPERIMENTAL

Patients in group C will receive monotherapy of sorafenib.

Drug: sorafenib

Interventions

hepatic resection PROCEDURE

palliative hepatectomy followed by sorafenib

Also known as: Group A (hepatectomy)

A, surgery

transcatheter hepatic arterial chemoembolization PROCEDURE

TACE followed by sorafenib

Also known as: Group B (TACE)

B, TACE

sorafenib DRUG

sorafenib monotherapy, 400mg Bid, continuously

Also known as: Group C (sorafenib)

C, sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Minshan Chen, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Hepatobiliary Surgery, Cancer Center

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 4, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: January 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)