HepatectomyPhase 42011PTAHCCNCT01409499
Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)
A Phase 4 study testing hepatic resection, transcatheter hepatic arterial chemoembolization and sorafenib in people with Hepatectomy and Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy, Hepatocellular Carcinoma, Sorafenib
- What is being tested?
- hepatic resection, transcatheter hepatic arterial chemoembolization and sorafenib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatectomy, Hepatocellular Carcinoma, Sorafenib
- Being tested
- hepatic resection, transcatheter hepatic arterial chemoembolization, sorafenib
- Keywords
- hepatocellular carcinoma, treatments, survival
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic resectionProcedure or surgery
Also called Group A (hepatectomy)
palliative hepatectomy followed by sorafenib
transcatheter hepatic arterial chemoembolizationProcedure or surgery
Also called Group B (TACE)
TACE followed by sorafenib
sorafenibDrug
Also called Group C (sorafenib)
sorafenib monotherapy, 400mg Bid, continuously
| Study group | Role | What they receive |
|---|---|---|
| A, surgery | Experimental | The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy. Receives: Procedure: hepatic resection |
| B, TACE | Experimental | Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy. Receives: Procedure: transcatheter hepatic arterial chemoembolization |
| C, sorafenib | Experimental | Patients in group C will receive monotherapy of sorafenib. Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
defined as the time from the first treatment to death
Measured: anticipate 6-12 months
Secondary outcomes (3)
Progression Free Survival (PFS)
defined as the time from the first treatment to the first progression disease is confirmed by radiological methods
Measured: anticipate 3-6 months
AEs and SAEs
according to CTC AE 3.0
Measured: anticipate 6-12 months
cost of treatments
to compare costs of different treatments
Measured: 3 months in average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XU li, Sun Yat-sen University
- Investigators
- Minshan Chen, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409499
- Sponsor's protocol ID
- 2011PTAHCC
- Acronym
- 2011PTAHCC
- Status last verified
- Sep 2018
- First submitted
- 1 Aug 2011
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01409499
- Acronym / sponsor ID
- 2011PTAHCC / 2011PTAHCC
- Conditions
- Hepatectomy, Hepatocellular Carcinoma, Sorafenib
- Keywords
- hepatocellular carcinoma, treatments, survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A, surgery | Experimental | Procedure: hepatic resectionThe patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy. |
| B, TACE | Experimental | Procedure: transcatheter hepatic arterial chemoembolizationPatients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy. |
| C, sorafenib | Experimental | Drug: sorafenibPatients in group C will receive monotherapy of sorafenib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Tumor number <=2.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatic resectionAlso: Group A (hepatectomy)palliative hepatectomy followed by sorafenib | Procedure or surgery | A, surgery |
| transcatheter hepatic arterial chemoembolizationAlso: Group B (TACE)TACE followed by sorafenib | Procedure or surgery | B, TACE |
| sorafenibAlso: Group C (sorafenib)sorafenib monotherapy, 400mg Bid, continuously | Drug | C, sorafenib |
Primary outcome
Overall survival (OS)
Time frame: anticipate 6-12 months
defined as the time from the first treatment to death
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: anticipate 3-6 months
AEs and SAEs
Time frame: anticipate 6-12 months
cost of treatments
Time frame: 3 months in average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minshan Chen, M.D. principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hepatic resection, transcatheter hepatic arterial chemoembolization and sorafenib in people with Hepatectomy and Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: anticipate 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.