Hepatocellular CarcinomaPhase 1/2SILIUSNCT00933816
Study of Sorafenib In Combination With Low-dose 5-fluorouracil/Cisplatin (FP) Intraarterial Infusion Chemotherapy
A Phase 1/2 study testing sorafenib, cisplatin, fluorouracil in people with Hepatocellular Carcinoma, run by Kindai University at 3 sites in Japan.
Trial summary
The purpose of this study is to determine the recommended dose of the combination therapy of sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this combination therapy in the recommended dose… 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?
- sorafenib, cisplatin, fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2009to Oct 2010
- Phase
- Phase 1/2
- 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
- 20 Years and older.
- Life expectancy of at least 12 weeks at the pre-treatment evaluation.
- Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography.
- Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
- One treatment of hepatic arterial infusion chemotherapy without implanted catheter system is allowed.
- ECOG Performance status of 0 or 1.
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- Cirrhotic status of Child-Pugh class A or B.
- Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:
- Hemoglobin 8.5 g/dl
- Granulocytes 1500/μL
- Platelet count 50,000 /μL
- PT-INR 2.3 or PT 6 seconds above control
- Total serum bilirubin 2 mg/dl
- AST(SGOT) and ALT(SGPT) 5 × upper limit of normal
- Serum creatinine 1.5 × upper limit of normal
- Amylase 5 × upper limit of normal
- Written Informed Consent must be obtained.
Who cannot join
- Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry
- Renal failure
- Any heart disease as follows
- Congestive heart failure defined as NYHA class III or IV
- Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening
- Serious cardiac arrhythmia
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- Serious hypertension
- Active clinically serious infections.
- Active chicken pox.
- Auditory disorder.
- Known history of HIV infection.
- Known metastatic or meningeal tumors.
- Extrahepatic tumor spread.
- History of seizure disorder.
- Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
- Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization).
- Any history of treatment as follows:
- Treatment with the agent which induces CYP3A4
- Surgical procedure within 4 weeks prior to start of study drug
- History of organ allograft
- Patients unable to swallow oral medications.
- Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
- Medication that may affect to the absorption of drug or pharmacokinetics.
- Any disease or disorder that may affect the evaluation of study drug.
- Entry to the other clinical trial within 4 weeks prior to entry to this study.
- Pregnant or breast-feeding patients.
- Known allergy to the investigational agent or any agent given in association with this trial.
- Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results.
- Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Kurume University Medical Center
Kurume, Fukuoka, 839-0863
Ogaki Municipal Hospital
Oogaki, Gifu, 503-8502
Kinki University School of Medicine
Ōsaka-sayama, Osaka, 589-8511
About this study
Official title: Phase I/II Study of Sorafenib In Combination With Low-dose FP Intraarterial Infusion Chemotherapy
The purpose of this study is to determine the recommended dose of the combination therapy of sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this combination therapy in the recommended dose (Phase II).
Read the detailed description
In Phase I, there will be 9 to 18 patients enrolled. Cohorts of 3 to 6 patients will receive escalated dose of cisplatin and fluorouracil until the MTD is reached. There will be no intra-patient dose escalation. Sorafenib will be administered orally at a dose of 400mg bid for 28 days in the all patients. Cisplatin at the dose of 10-20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 170-330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days and 3 cycles of this combination therapy will be continued. At the end of each cycle, adverse effect will be evaluated and dose escalation will be determined. In Phase II, there will be 28 patients enrolled. Time to progression of this combination therapy at the recommended dose will be evaluated.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- sorafenib, cisplatin, fluorouracil
- Keywords
- sorafenib, intraarterial infusion chemotherapy, Low dose FP, 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.
sorafenib, cisplatin, fluorouracilDrug
Also called sorafenib with hepatic arterial infusion of low dose FP
Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in the all patients. Cisplatin at the dose of 10-20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 170-330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days and 3 cycles of this combination therapy will be continued.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib with Low-dose FP | Experimental | Not described Receives: Drug: sorafenib, cisplatin, fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity in phase I and Time to progression in Phase II
Measured: Every 4 weeks
Secondary outcomes (5)
Phase I and II: Overall survival (OS)
Measured: Every day
Phase I and II: Progression free survival (PFS)
Measured: Every four weeks
Phase I: Time to progression (TTP)
Measured: Every four weeks
Phase I and II: Response Rate (RR)
Measured: Every four weeks
Phase I and II: Adverse effect (AE)
Measured: Every four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2010
- Study completionOct 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Investigators
- Masatoshi Kudo, Principal investigator, Kindai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933816
- Sponsor's protocol ID
- JLOG0901
- Acronym
- SILIUS
- Status last verified
- Nov 2010
- First submitted
- 1 Jul 2009
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Sorafenib In Combination With Low-dose FP Intraarterial Infusion Chemotherapy
- ClinicalTrials.gov ID
- NCT00933816
- Acronym / sponsor ID
- SILIUS / JLOG0901
- Conditions
- Hepatocellular Carcinoma
- Keywords
- sorafenib, intraarterial infusion chemotherapy, Low dose FP, cisplatin, fluorouracil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Jul 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 purpose of this study is to determine the recommended dose of the combination therapy of sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this combination therapy in the recommended dose (Phase II).
Detailed description
In Phase I, there will be 9 to 18 patients enrolled. Cohorts of 3 to 6 patients will receive escalated dose of cisplatin and fluorouracil until the MTD is reached. There will be no intra-patient dose escalation. Sorafenib will be administered orally at a dose of 400mg bid for 28 days in the all patients. Cisplatin at the dose of 10-20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 170-330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days and 3 cycles of this combination therapy will be continued. At the end of each cycle, adverse effect will be evaluated and dose escalation will be determined. In Phase II, there will be 28 patients enrolled. Time to progression of this combination therapy at the recommended dose will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib with Low-dose FP | Experimental | Drug: sorafenib, cisplatin, fluorouracil |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 20 Years and older.
- Life expectancy of at least 12 weeks at the pre-treatment evaluation.
- Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography.
- Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
- One treatment of hepatic arterial infusion chemotherapy without implanted catheter system is allowed.
Key exclusion criteria (29 listed)
- Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry
- Renal failure
- Any heart disease as follows
- Active clinically serious infections.
- Active chicken pox.
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 |
|---|---|---|
| sorafenib, cisplatin, fluorouracilAlso: sorafenib with hepatic arterial infusion of low dose FPSorafenib will be administered orally at a dose of 400 mg bid for 28 days in the all patients. Cisplatin at the dose of 10-20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 170-330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days and 3 cycles of this combination therapy will be continued. | Drug | Sorafenib with Low-dose FP |
Primary outcome
Dose limiting toxicity in phase I and Time to progression in Phase II
Time frame: Every 4 weeks
5 secondary outcomes
Phase I and II: Overall survival (OS)
Time frame: Every day
Phase I and II: Progression free survival (PFS)
Time frame: Every four weeks
Phase I: Time to progression (TTP)
Time frame: Every four weeks
Phase I and II: Response Rate (RR)
Time frame: Every four weeks
Phase I and II: Adverse effect (AE)
Time frame: Every four weeks
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 25 Nov 2010.
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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.
Masatoshi Kudo principal investigator
Kindai University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sorafenib, cisplatin, fluorouracil in people with Hepatocellular Carcinoma, run by Kindai University at 3 sites 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 17 inclusion and 29 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Dose limiting toxicity in phase I and Time to progression in Phase II (time frame: Every 4 weeks). 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 25 Nov 2010; AzTrials last refreshed its copy on 7 Nov 2026.