Hepatocellular CarcinomaPhase 2NCT01834963
P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
A Phase 2 study testing Interferon Alfa、Fluorouracil and Cisplatin、Fluorouracil in people with Hepatocellular Carcinoma, run by Kansai Hepatobiliary Oncology Group at 1 site in Japan.
Trial summary
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Interferon Alfa、Fluorouracil and Cisplatin、Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Feb 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
- surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
- 20 years old or more.
- Eastern Cooperative Oncology Group Performance status of 0 or 1.
- Life expectancy of at least 6 months at the pre-treatment evaluation.
- Child-Pugh class A or B.
Show all 9Show fewer
- Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
- white blood cell count >= 2000/microliter, Neutrophil >= 1000/microliter, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/microliter, Total Bilirubin <= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min
- -
Who cannot join
- Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
- Extrahepatic tumor spread which affects patient's prognosis.
- Hepatic encephalopathy
- Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- Active double cancer
Show all 9Show fewer
- Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.
- 11) others, in the investigator's judgment.
- -
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka University, Graduate School of Medicine
Osaka, 565-0871
Hiroshi Wada, +81-6-6879-3251
About this study
Official title: Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.
Read the detailed description
No standard treatment has been established for highly advanced hepatocellular carcinoma (HCC) invading the major branches of the portal vein except for sorafenib. Some reports suggested that hepatic arterial infusion chemotherapy improved survival of these patients. Other reports indicated surgical intervention improved that survival. However, there is no standard adjuvant therapy after liver resection for the patients with HCC with portal vein tumor thrombus in the main or first branch of the portal vein. Our preliminary results showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a postoperative therapy prolonged disease-free and overall survival after liver resection. Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising regimen for advanced HCC.
Herein, the investigators planed the study to evaluate efficacy (two year survival as primary outcome, and overall-survival as secondary outcome) and safety ( as secondary outcome) in hepatic arterial infusion chemotherapy with continuous infusion of 5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and cisplatin, and to compare the efficacy as randomized control trial.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Interferon Alfa、Fluorouracil, Cisplatin、Fluorouracil
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Alfa、FluorouracilDrug
Also called Interferon Alfa ; IFN、, Fluorouracil ; 5-FU
Hepatic Arterial Infusion of 5-fluorouracil combined with systemic administration of Interferon-alpha
Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks
Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Cisplatin、FluorouracilDrug
Also called Cisplatin ； Cispulan, Fluorouracil ; 5-FU
Hepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP)
Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks
Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Interferon Alfa、Fluorouracil | Experimental | Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks
Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks Receives: Drug: Interferon Alfa、Fluorouracil |
| Cisplatin、Fluorouracil | Experimental | Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks
Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks Receives: Drug: Cisplatin、Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year overall survival rate
Duration: From randomization to evidenced death.
Rate: Number of patients with evidenced death / number of total patients.
2 year survival rate: survival rate at two-year from the randomization
Measured: Two years
Secondary outcomes (3)
Progression free survival time
Progression free survival time from randomization to tumor progression based on RECIST or recurrence after curative surgery was calculated by Kaplan Meier methods.
Measured: two years
Overall survival time
Overall survival time from randomization to evidence death was calculated by Kaplan Meier methods.
Measured: two years
toxicity
The incidence of adverse events evaluated by CTCAE Ver4.0.
Measured: At the end of hepatic arterial infusion chemotherapy (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2018
- Study completionFeb 2020 (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.
- 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansai Hepatobiliary Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hiroaki Nagano, MD, PhD, Study director, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834963
- Sponsor's protocol ID
- KHBO1207
- Other IDs
- UMIN000010425
- Status last verified
- Aug 2017
- First submitted
- 16 Apr 2013
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.
- ClinicalTrials.gov ID
- NCT01834963
- Acronym / sponsor ID
- KHBO1207
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Kansai Hepatobiliary Oncology GroupResearch network
- Study start
- Mar 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 18 Apr 2013 (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.
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.
Detailed description
No standard treatment has been established for highly advanced hepatocellular carcinoma (HCC) invading the major branches of the portal vein except for sorafenib. Some reports suggested that hepatic arterial infusion chemotherapy improved survival of these patients. Other reports indicated surgical intervention improved that survival. However, there is no standard adjuvant therapy after liver resection for the patients with HCC with portal vein tumor thrombus in the main or first branch of the portal vein. Our preliminary results showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a postoperative therapy prolonged disease-free and overall survival after liver resection. Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising regimen for advanced HCC.
Herein, the investigators planed the study to evaluate efficacy (two year survival as primary outcome, and overall-survival as secondary outcome) and safety ( as secondary outcome) in hepatic arterial infusion chemotherapy with continuous infusion of 5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and cisplatin, and to compare the efficacy as randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon Alfa、Fluorouracil | Experimental | Drug: Interferon Alfa、FluorouracilInterferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks |
| Cisplatin、Fluorouracil | Experimental | Drug: Cisplatin、FluorouracilCisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
- surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
- 20 years old or more.
- Eastern Cooperative Oncology Group Performance status of 0 or 1.
- Life expectancy of at least 6 months at the pre-treatment evaluation.
Key exclusion criteria (9 listed)
- Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
- Extrahepatic tumor spread which affects patient's prognosis.
- Hepatic encephalopathy
- Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
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 |
|---|---|---|
| Interferon Alfa、FluorouracilAlso: Interferon Alfa ; IFN、, Fluorouracil ; 5-FUHepatic Arterial Infusion of 5-fluorouracil combined with systemic administration of Interferon-alpha Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks | Drug | Interferon Alfa、Fluorouracil |
| Cisplatin、FluorouracilAlso: Cisplatin ； Cispulan, Fluorouracil ; 5-FUHepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP) Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks | Drug | Cisplatin、Fluorouracil |
Primary outcome
Two-year overall survival rate
Time frame: Two years
Duration: From randomization to evidenced death. Rate: Number of patients with evidenced death / number of total patients. 2 year survival rate: survival rate at two-year from the randomization
3 secondary outcomes
Progression free survival time
Time frame: two years
Overall survival time
Time frame: two years
toxicity
Time frame: At the end of hepatic arterial infusion chemotherapy (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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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.
Hiroaki Nagano, MD, PhD study director
Osaka University Graduate School of Medicine
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 Interferon Alfa、Fluorouracil and Cisplatin、Fluorouracil in people with Hepatocellular Carcinoma, run by Kansai Hepatobiliary Oncology Group at 1 site in Japan.
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 9 inclusion and 9 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 18 May 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year overall survival rate (time frame: Two years). 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 18 May 2018.