UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005910 |
|---|---|
| Receipt number | R000006989 |
| Scientific Title | Safety Evaluation of the Maintenance treatment of Sorafenib in Hepatocellular carcinoma patients with Tumor thrombus after palliative surgery |
| Date of disclosure of the study information | 2011/07/06 |
| Last modified on | 2019/01/06 10:07:20 |
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Basic information
Public title
Safety Evaluation of the Maintenance treatment of Sorafenib in Hepatocellular carcinoma patients with Tumor thrombus after palliative surgery
Acronym
Sorafenib for TT
Scientific Title
Safety Evaluation of the Maintenance treatment of Sorafenib in Hepatocellular carcinoma patients with Tumor thrombus after palliative surgery
Scientific Title:Acronym
Sorafenib for TT
Region
| Japan |
Condition
Condition
To evaluate the safety of sorafenib as a maintenance therapy after the surgical resection of hepatocellular carcinoma (HCC) with macroscopic vascular invasion (Vp, Vv, B).
Classification by specialty
| Hepato-biliary-pancreatic medicine | Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of sorafenib as a maintenance therapy after the surgical resection of hepatocellular carcinoma (HCC) with macroscopic vascular invasion (Vp, Vv, B).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
incidence of adverse events, hepatic reserve (ICGR-15), hepatic function (ALT, T-cho, T-Bil), and Child-Pugh class and score after the start of treatment with sorafenib
Key secondary outcomes
progression-free survival (PFS), time to progression (TTP), overall survival (OS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
When normal performance status and liver function are restored after the surgical resection of HCC with vascular invasion (#; 4 weeks to < 8 weeks after hepatectomy or ; 2 weeks to < 4 weeks after postoperative TAE), study treatment will be started as follows:
1)Subjects classified as Child-Pugh class A: Start sorafenib at an initial dose of 800 mg/day.
2)Subjects classified as Child Pugh B (7): Start sorafenib at an initial dose of 400 mg/day. When a subject meets the following dose-increase criteria 4 weeks later, increase the dose to 800 mg/day. When a subject fails to meet any of the criteria at this time, check his/her conformity to the criteria every 2 weeks.
Interventions/Control_2
After the first dose of sorafenib, treatment will be continued until recurrence is noted. When a subject has a disease-free interval of more than one year, treatment will be continued in principle for one year; subsequent treatment will be determined in accordance with the opinions of the subject's doctor and his/her wishes.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients aged > 20 years to < 85 years;
(2)Patients with recurrent disease who received prior treatment at least 2 years before surgery;
(3)Patients in whom a preoperative diagnosis of HCC was made histologically or clinically (diagnostic imaging and tumor marker diagnosis);
(4)Patients with preoperative evidence of macroscopic vascular invasion (Vp, Vv, B);
(5)Patients with preoperative evidence of measurable disease on a contrast-enhanced CT or MRI scan;
(6)Patients who underwent successful surgical resection of HCC with macroscopic vascular invasion, or those with gross residual disease after surgery who underwent postoperative TAE;
(7)Patients without any carry-over effects of prior treatment or adverse reactions (prior to the study, a treatment-free period of > 4 weeks to < 8 weeks is required after surgery; for those with gross residual disease after surgery, a treatment-free period of > 2 weeks to < 4 weeks is required after postoperative TAE);
(8)Patients with a Child-Pugh score of >7
(9)Patients with an ECOG performance status (PS) of 0 or 1;
(10)Patients with intact function of vital organs (to be confirmed within 2 weeks before the start of study treatment);
(a)Neutrophil count:>1,500/uL
(b)Serum albumin: >3.0 g/dL
(c)Platelets:>50,000/uL
(d)Hemoglobin:>7.5 g/dL
(e)Total bilirubin: <1.5 mg/dL
(f)Serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT):<200 IU/L
(g)Serum creatinine: <1.5
x ULN at the study site
(11)Patients who can comply with the study procedures including hospital visits, study treatment, and laboratory tests; and
(12)Patients who gave written informed consent prior to the study.
Key exclusion criteria
(1)Patients treated with sorafenib or other molecular target drugs within 3 months before surgery;
(2)Patients with a history of allergic reaction to sorafenib;
(3)Pregnant and breastfeeding women or those who may possibly be pregnant;
(4)Patients with serious complications (whether preoperative or postoperative);
(5)Patients with distant metastasis;
(6)Patients with other active malignancies (e.g., brain tumor);
(7)Patients with underlying diseases other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic hepatitis);
(8)Patients with moderate or severe renal dysfunction (eGFR < 30 mL/min) including those on dialysis;
(9)Patients with asthma;
(10)Patients with uncontrolled hypertension or with thromboembolism, ischemic heart disease, unstable angina pectoris, heart failure, or cerebrovascular disorder that may affect the operability of the disease;
(11)Patients with clinically relevant ascites (refractory ascites requiring therapeutic paracentesis);
(12)Patients with previous liver transplantation;
(13) Patients with esophageal varices that may cause bleeding (those who had gastrointestinal bleeding in the past month);
(14)Patients with a current or past history of hepatic encephalopathy;
(15)Patients under treatment with drugs affecting the activity of CYP3A4 or UGT1A9 (e.g., rifampicin) or drugs that may affect the serum concentration of sorafenib;
(16)Patients orally taking crude drugs approved for the treatment of cancer (e.g., Sho-saiko-to);
(17)Patients with diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or
(18)Patients considered to be ineligible for participation in the study by the investigator or subinvestigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Inoue |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
Tokyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2011 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 02 | Day |
Last modified on
| 2019 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006989
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