- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409499
Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC) (2011PTAHCC)
September 9, 2018 updated by: XU li, Sun Yat-sen University
A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
180
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A, surgery
The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.
|
palliative hepatectomy followed by sorafenib
Other Names:
|
Experimental: B, TACE
Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.
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TACE followed by sorafenib
Other Names:
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Experimental: C, sorafenib
Patients in group C will receive monotherapy of sorafenib.
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sorafenib monotherapy, 400mg Bid, continuously
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: anticipate 6-12 months
|
defined as the time from the first treatment to death
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anticipate 6-12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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anticipate 3-6 months
|
AEs and SAEs
Time Frame: anticipate 6-12 months
|
according to CTC AE 3.0
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anticipate 6-12 months
|
cost of treatments
Time Frame: 3 months in average
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to compare costs of different treatments
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3 months in average
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Minshan Chen, M.D., Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
August 1, 2011
First Submitted That Met QC Criteria
August 3, 2011
First Posted (Estimate)
August 4, 2011
Study Record Updates
Last Update Posted (Actual)
September 11, 2018
Last Update Submitted That Met QC Criteria
September 9, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- 2011PTAHCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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