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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005910
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006989

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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