Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC) (2011PTAHCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01409499
Recruitment Status : Recruiting
First Posted : August 4, 2011
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
XU li, 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.

Condition or disease Intervention/treatment Phase
Hepatectomy Hepatocellular Carcinoma Sorafenib Procedure: hepatic resection Procedure: transcatheter hepatic arterial chemoembolization Drug: sorafenib Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
Study Start Date : January 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A, surgery
The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.
Procedure: hepatic resection
palliative hepatectomy followed by sorafenib
Other Name: Group A (hepatectomy)
Experimental: B, TACE
Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.
Procedure: transcatheter hepatic arterial chemoembolization
TACE followed by sorafenib
Other Name: Group B (TACE)
Experimental: C, sorafenib
Patients in group C will receive monotherapy of sorafenib.
Drug: sorafenib
sorafenib monotherapy, 400mg Bid, continuously
Other Name: Group C (sorafenib)

Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: anticipate 6-12 months ]
    defined as the time from the first treatment to death

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: anticipate 3-6 months ]
    defined as the time from the first treatment to the first progression disease is confirmed by radiological methods

  2. AEs and SAEs [ Time Frame: anticipate 6-12 months ]
    according to CTC AE 3.0

  3. cost of treatments [ Time Frame: 3 months in average ]
    to compare costs of different treatments

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01409499

Contact: LI XU, M.D 862087343582
Contact: Minshan Chen, M.D 862087343117

China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: LI XU, M.D.    862087343582   
Sub-Investigator: LI XU, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Minshan Chen, M.D. Sun Yat-sen University

Responsible Party: XU li, Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University Identifier: NCT01409499     History of Changes
Other Study ID Numbers: 2011PTAHCC
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by XU li, Sun Yat-sen University:
hepatocellular carcinoma, treatments, survival

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs