Status:
COMPLETED
Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatectomy
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01409499
Start Date
January 1 2011
End Date
January 1 2018
Last Update
September 11 2018
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060