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

This study is currently recruiting participants.
Verified October 2012 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
XU li, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01409499
First received: August 1, 2011
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Sorafenib is the Present Standard Treatment for Advanced HCC
More Active Treatments Were Used in Clinical Practice
Whether Active Treatments Could Give Survival Benefit?
Procedure: hepatectomy
Procedure: transcatheter hepatic arterial chemoembolization
Drug: sorafenib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: anticipate 6-12 months ] [ Designated as safety issue: No ]
    defined as the time from the first treatment to death


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: anticipate 3-6 months ] [ Designated as safety issue: No ]
    defined as the time from the first treatment to the first progression disease is confirmed by radiological methods

  • AEs and SAEs [ Time Frame: anticipate 6-12 months ] [ Designated as safety issue: Yes ]
    according to CTC AE 3.0

  • cost of treatments [ Time Frame: 3 months in average ] [ Designated as safety issue: No ]
    to compare costs of different treatments


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, surgery
The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.
Procedure: hepatectomy
palliative hepatectomy followed by sorafenib
Other Name: Group A
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
Experimental: C, sorafenib
Patients in group C will receive monotherapy of sorafenib.
Drug: sorafenib
sorafenib monotherapy, 400mg Bid, continuously
Other Name: Group C

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409499

Contacts
Contact: LI XU, M.D 862087343582 xuli@sysucc.org.cn
Contact: Minshan Chen, M.D 862087343117 chenmsh@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: LI XU, M.D.    862087343582    xuli@sysucc.org.cn   
Sub-Investigator: LI XU, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Minshan Chen, M.D. Sun Yat-sen University
  More Information

No publications provided

Responsible Party: XU li, Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01409499     History of Changes
Other Study ID Numbers: 2011PTAHCC
Study First Received: August 1, 2011
Last Updated: October 4, 2012
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014