A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
18 Years
N/A
Both
Sorafenib is the Present Standard Treatment for Advanced HCC, More Active Treatments Were Used in Clinical Practice, Whether Active Treatments Could Give Survival Benefit?
Trial Information
A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival (OS)
Outcome Description:
defined as the time from the first treatment to death
Outcome Time Frame:
anticipate 6-12 months
Safety Issue:
No
Principal Investigator
Minshan Chen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sun Yat-sen University
Authority:
China: Ministry of Health
Study ID:
2011PTAHCC
NCT ID:
NCT01409499
Start Date:
January 2011
Completion Date:
January 2016
Related Keywords:
- Sorafenib is the Present Standard Treatment for Advanced HCC
- More Active Treatments Were Used in Clinical Practice
- Whether Active Treatments Could Give Survival Benefit?
- hepatocellular carcinoma, treatments, survival
- Carcinoma
- Carcinoma, Hepatocellular
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