Hepatocellular CarcinomaPhase 2NCT00849264
Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients
A Phase 2 study testing chemotherapy with endostar, treatment with CBP and 5-FU and treatment with endostar, CBP and 5-FU in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombus, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
This study is working to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hepatocellular Carcinoma, Portal Vein Tumor Thrombus
- What is being tested?
- chemotherapy with endostar, treatment with CBP and 5-FU and treatment with endostar, CBP and 5-FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 2
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients > 30 years and <=60 years of age.
- with a clinical diagnosis of primary liver cancer with PVTT, without any adjuvant therapy.
- resectable tumors in the liver.
- PVTT type for II or III (based on the PVTT type system established by our groups), confirmed through pre-operative imaging and pathologic examination.
- liver function grade A or B of the Child-Pugh classification.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hb ≥95g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³.
- Patients who can understand this trial and have signed information consent.
Who cannot join
- have had an allergic reaction following iodine or chemotherapeutic drugs.
- with extrahepatic metastasis.
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
- liver function:Child C.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: a Randomized Controlled Study of Surgical Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients
This study is working to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.
Read the detailed description
Primary liver cancer (PLC) has a great tendency to invade portal vein intravascularly, results in the formation of portal vein tumor thrombus (PVTT), which is a crucial factor that can worsen the prognosis of patients with PLC.
In clinical, various treatments have been applied to improve this short-term prognosis, but there was no identical indication for treatment of PLC patients with different PVTT.
The objective of this study is to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.
- Being tested
- chemotherapy with endostar, treatment with CBP and 5-FU, treatment with endostar, CBP and 5-FU
- Keywords
- hepatocellular carcinoma, portal vein tumor thrombus, surgical comprehensive treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy with endostarDrug
Also called chemotherapy with endostar group
15mg/d×14d
treatment with CBP and 5-FUDrug
Also called treatment with CBP and 5-FU group
CBP 300mg/d×2d，5-FU 1000mg/d×5d
treatment with endostar, CBP and 5-FUDrug
Also called endostar, CBP and 5-FU group
CBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar Receives: Drug: chemotherapy with endostar |
| B | Active comparator | PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU Receives: Drug: treatment with CBP and 5-FU |
| C | Experimental | PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU Receives: Drug: treatment with endostar, CBP and 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 2010
Secondary outcomes (1)
disease-free survival
Measured: 1,2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Feng Shen, M.D., Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849264
- Sponsor's protocol ID
- EHBH-RCT-2008-004
- Status last verified
- Mar 2016
- First submitted
- 19 Feb 2009
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized Controlled Study of Surgical Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT00849264
- Acronym / sponsor ID
- EHBH-RCT-2008-004
- Keywords
- hepatocellular carcinoma, portal vein tumor thrombus, surgical comprehensive treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Feb 2009 (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.
This study is working to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.
Detailed description
Primary liver cancer (PLC) has a great tendency to invade portal vein intravascularly, results in the formation of portal vein tumor thrombus (PVTT), which is a crucial factor that can worsen the prognosis of patients with PLC.
In clinical, various treatments have been applied to improve this short-term prognosis, but there was no identical indication for treatment of PLC patients with different PVTT.
The objective of this study is to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: chemotherapy with endostarPLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar |
| B | Active comparator | Drug: treatment with CBP and 5-FUPLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU |
| C | Experimental | Drug: treatment with endostar, CBP and 5-FUPLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female patients > 30 years and <=60 years of age.
- with a clinical diagnosis of primary liver cancer with PVTT, without any adjuvant therapy.
- resectable tumors in the liver.
- PVTT type for II or III (based on the PVTT type system established by our groups), confirmed through pre-operative imaging and pathologic examination.
- liver function grade A or B of the Child-Pugh classification.
Key exclusion criteria (4 listed)
- have had an allergic reaction following iodine or chemotherapeutic drugs.
- with extrahepatic metastasis.
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
- liver function:Child C.
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 |
|---|---|---|
| chemotherapy with endostarAlso: chemotherapy with endostar group15mg/d×14d | Drug | A |
| treatment with CBP and 5-FUAlso: treatment with CBP and 5-FU groupCBP 300mg/d×2d，5-FU 1000mg/d×5d | Drug | B |
| treatment with endostar, CBP and 5-FUAlso: endostar, CBP and 5-FU groupCBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d | Drug | C |
Primary outcome
overall survival
Time frame: 2010
1 secondary outcome
disease-free survival
Time frame: 1,2 and 3 years
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 1 Apr 2016.
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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.
Feng Shen, M.D. study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy with endostar, treatment with CBP and 5-FU and treatment with endostar, CBP and 5-FU in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombus, run by Eastern Hepatobiliary Surgery Hospital 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 7 inclusion and 4 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 1 Apr 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (time frame: 2010). 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 1 Apr 2016.