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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004313 |
Receipt No. | R000005049 |
Scientific Title | A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Non-blind dosage gradual increase study |
Date of disclosure of the study information | 2010/10/03 |
Last modified on | 2020/07/13 |
Basic information | ||
Public title | A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study |
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Acronym | A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study |
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Scientific Title | A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study |
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Scientific Title:Acronym | A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study |
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Region |
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Condition | ||
Condition | Hepatocellular carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine maximum tolerated dose(MTD) and recommended dose(RD) of combination therapy of 5-FU and sorafenib in patients with hepatocellular carcinoma unresectable and unsuitable for local therapy. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | occurrence of dose limiting toxicity |
Key secondary outcomes | Adversed events
Objective tumor response Change of tumor markers |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | The combination therapy of continuous intravenous infusion of 5-FU and sorafenib | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Age >= 20 years at informed consent.
2) Patients diagnosed with hepatocellular carcinoma by histologycally or clinically (with diagnostic imaging and tumor makers), and No indication for surgical resection, local therapy. 3) Patients who have target lesions that can be measured with imaging CT or imaging MRI. At least one or more target regions are there that have no local therapy (surgery, radiation therapy, transarterial chemoembolization, transcatheter arterial infusion, radiofrequency ablation, percutaneous ethanol injection etc.). Regions are evaluated measurable judged to be progress after any local therapy. 4) No carry-over effect or adverse drug reaction of prior treatments. Make following intervals from previous treatments; 2 weeks from a surgery and percutaneous local therapy, 4 weeks from transarterial chemoembolization, transcatheter arterial infusion and radiations. 5) Child-pugh A 6) Performance status (ECOG scale):0 or 1 7) The function of the major organ is kept as satisfied by the following requirement. Within 14 days before study entry, Neutrophil >= 1,500/microL Platelets >= 50,000/microL Hemoglobin >= 10g/dL Total bilirubin < 2.0mg/dL AST or ALT <= 5 *Upper limit of Normal(ULN) Cr <= 1.5 *ULN 8) Patients are considered to keeping procedure of this study such as visit, compliance, having laboratory tests. 9) Patients with written informed consent it was based on the full understanding and free will of themselves after having detailed explanations of the study. |
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Key exclusion criteria | 11) Treatment with sorafenib or other molecular target drugs in past.
2) Any systemic chemotherapy in past. 3) Patients with ascites possessed clinical meaning. (Requiring drainage) 4) After liver transplantation 5) Esophageal varices with bleeding risk 6) Within 12 months before study entry, following events were happened; acute myocardial infarction, unstable angina, heart failure, cerebrovascular diseases. 7) Hepatic Encephalopathy. (Including as a previous disease) 8) Brain tumors. 9) Hemodialysis. 10) Gastrointestinal bleeding was happened within 1 month before study entry. 11) Active second primary malignancies. 12) Treating with CYP3A4 inducing agents. (rifampicin, phenobarbital, phenytoin, carbamazepine, dexamethasone etc.) 13) Patients with following complications; Arrhythmias coming under Grade2 or more of NCI CTCAE v4.0, uncontrolled hypertension 14) Contraindication of 5-FU and sorafenib 15) Patient with taking herbal medicine approved as a treatment of cancer. (shosaikoto, etc.) 16) Patients with infection of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases. 17) Any patients are considered unsuitable to participate in the study. |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido University Hospital | ||||||
Division name | The Third Department of Internal Medicine(Gastroenterology and Hematology) | ||||||
Zip code | |||||||
Address | Kita 14,Nishi 5, Kita-ku, Sapporo, Japan | ||||||
TEL | 011-716-1161(5920) | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido University Hospital | ||||||
Division name | The Third Department of Internal Medicine(Gastroenterology and Hematology) | ||||||
Zip code | |||||||
Address | Kita 14,Nishi 5, Kita-ku, Sapporo, Japan | ||||||
TEL | 011-716-1161(5920) | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Hokkaido University Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Sapporo city general hospital
Hokkaido Gastroenterology Hospital Hospital Hakodate Hokkaido |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 北海道大学病院(北海道) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 0 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005049 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |