Hepatocellular CarcinomaNCT01033578
Efficacy of Postoperative Adjuvant Treatments for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
A study testing PVIC, TACE in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor thrombosis( PVTT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- PVIC, TACE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Oct 1999to Dec 2010
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- Hepatocellular carcinoma with portal vein tumor thrombosis in the first branch and/or main trunk of the portal vein confirmed by preoperative radiologic investigations, intraoperative exploration and postoperative pathology.
- No extrahepatic metastasis
- No previous management
- The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative ultrasonography
- Good or moderate hepatic function (Child-Pugh Class A or B)
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
Who cannot join
- Refuse to participate
- Absolute neutrophil count <1.5*109/L, hemoglobin < 80g/L or platelet count <50 * 109/L, transaminases greater than 3 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal, INR greater than 1.5 times of normal, which could not recover after treatment
- Ascites refractory to diuretics
- Variceal bleeding
- Severe diseases of the heart or Lung
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liver Cancer Insitute, Zhongshan Hospital
Shanghai, 200032
Jia Fan, Doctor, 86-21-64041990 ext. 2375, jiafan99@yahoo.com
Xiaoying Wang, Doctor, 86-21-64041990 ext. 2918, xiaoyingwang@fudan.edu.cn
About this study
Official title: Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor thrombosis( PVTT).
Read the detailed description
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the third major cause of cancer-related death. HCC is characterized by its propensity for portal vein invasion. Portal vein tumor thrombosis (PVTT) can be detected macroscopically in the portal vein in 44% to 62.2% of autopsy cases. The natural history of untreated HCC with PVTT is dismal. The median survival of such patients was reported to be 2.7 mouths.
Non-surgical therapies, such as systemic/regional chemotherapy and transcatheter arterial embolization / transcatheter arterial chemoembolization (TAE/TACE), are not effective in treating HCC with PVTT. With the improvement of surgical techniques, surgical resection has been reported to achieve promising results. However, the high rate of recurrence and metastasis constitutes one of the most important challenges in improving surgical efficacy for HCC with PVTT.
There is rare report about prevention and treatment of postoperative recurrence and metastasis for HCC with macroscopical PVTT patients. We previously found the postoperative portal vein infusion chemotherapy (PVIC) and TACE benefited PVTT patients, which required further prospective randomized controlled studies with large case number to support our findings. The randomized controlled trial was design to investigate the efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for HCC and PVTT.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- PVIC, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIC, TACEOther
Also called PVIC: portal vein infusion chemotherapy, TACE: transcatheter arterial chemoembolization
PVIC：5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) were continuously infused into portal vein through tube by a infusion pump. Treatment started 2 weeks after the operation and was repeated every 4 weeks for 6 cycles.
TACE: 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments Receives: Other: PVIC, TACE |
| PVIC Group | Experimental | Portal Vein Infusion Chemotherapy (PVIC): 5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) was continuously infused into portal vein through tube by a infusion pump implanted in operation. Treatment started 2 weeks after the operation and was repeated every 4 weeks for six cycles. Receives: Other: PVIC, TACE |
| TACE Group | Experimental | Transcatheter Arterial Chemoembolization (TACE): 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles. Receives: Other: PVIC, TACE |
| PVIC+TACE Group | Experimental | Combination of PVIC and TACE. PVIC started 2 weeks after operation and TACE started 6 weeks after operation. Both PVIC and TACE were repeated at 8 weeks intervals for 3 cycles. Receives: Other: PVIC, TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1-year, 3-year, 5-year
Secondary outcomes (1)
Time to Recurrence
Measured: 1-year, 3-year, 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startOct 1999
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
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.
- More trials run by Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jia Fan, Doctor, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033578
- Sponsor's protocol ID
- Fudan-LCI-PVTT-1
- Status last verified
- Oct 2009
- First submitted
- 15 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
- ClinicalTrials.gov ID
- NCT01033578
- Acronym / sponsor ID
- Fudan-LCI-PVTT-1
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 1999
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 16 Dec 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.
The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor thrombosis( PVTT).
Detailed description
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the third major cause of cancer-related death. HCC is characterized by its propensity for portal vein invasion. Portal vein tumor thrombosis (PVTT) can be detected macroscopically in the portal vein in 44% to 62.2% of autopsy cases. The natural history of untreated HCC with PVTT is dismal. The median survival of such patients was reported to be 2.7 mouths.
Non-surgical therapies, such as systemic/regional chemotherapy and transcatheter arterial embolization / transcatheter arterial chemoembolization (TAE/TACE), are not effective in treating HCC with PVTT. With the improvement of surgical techniques, surgical resection has been reported to achieve promising results. However, the high rate of recurrence and metastasis constitutes one of the most important challenges in improving surgical efficacy for HCC with PVTT.
There is rare report about prevention and treatment of postoperative recurrence and metastasis for HCC with macroscopical PVTT patients. We previously found the postoperative portal vein infusion chemotherapy (PVIC) and TACE benefited PVTT patients, which required further prospective randomized controlled studies with large case number to support our findings. The randomized controlled trial was design to investigate the efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for HCC and PVTT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Other: PVIC, TACEReceive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments |
| PVIC Group | Experimental | Other: PVIC, TACEPortal Vein Infusion Chemotherapy (PVIC): 5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) was continuously infused into portal vein through tube by a infusion pump implanted in operation. Treatment started 2 weeks after the operation and was repeated every 4 weeks for six cycles. |
| TACE Group | Experimental | Other: PVIC, TACETranscatheter Arterial Chemoembolization (TACE): 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles. |
| PVIC+TACE Group | Experimental | Other: PVIC, TACECombination of PVIC and TACE. PVIC started 2 weeks after operation and TACE started 6 weeks after operation. Both PVIC and TACE were repeated at 8 weeks intervals for 3 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 years
- Hepatocellular carcinoma with portal vein tumor thrombosis in the first branch and/or main trunk of the portal vein confirmed by preoperative radiologic investigations, intraoperative exploration and postoperative pathology.
- No extrahepatic metastasis
- No previous management
- The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative ultrasonography
Key exclusion criteria (5 listed)
- Refuse to participate
- Absolute neutrophil count <1.5*109/L, hemoglobin < 80g/L or platelet count <50 * 109/L, transaminases greater than 3 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal, INR greater than 1.5 times of normal, which could not recover after treatment
- Ascites refractory to diuretics
- Variceal bleeding
- Severe diseases of the heart or Lung
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 |
|---|---|---|
| PVIC, TACEAlso: PVIC: portal vein infusion chemotherapy, TACE: transcatheter arterial chemoembolizationPVIC：5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) were continuously infused into portal vein through tube by a infusion pump. Treatment started 2 weeks after the operation and was repeated every 4 weeks for 6 cycles. TACE: 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles. | Other | Control, PVIC Group, PVIC+TACE Group, TACE Group |
Primary outcome
Overall Survival
Time frame: 1-year, 3-year, 5-year
1 secondary outcome
Time to Recurrence
Time frame: 1-year, 3-year, 5-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
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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.
Jia Fan, Doctor study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVIC, TACE in people with Hepatocellular Carcinoma, run by Fudan 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Dec 2009. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Wang, Doctor (86-21-64041990 ext. 2918, xiaoyingwang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1-year, 3-year, 5-year). 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 16 Dec 2009.