UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005703
Receipt number R000006737
Scientific Title Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma.
Date of disclosure of the study information 2011/06/01
Last modified on 2015/07/29 14:28:01

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Basic information

Public title

Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma.

Acronym

HCC_Sor_CDDP_rP2

Scientific Title

Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma.

Scientific Title:Acronym

HCC_Sor_CDDP_rP2

Region

Japan


Condition

Condition

advanced hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy and safety of combination chemotherapy with sorafenib and hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Time to progression
Advrese events
Sever advrese events
Response rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The combination chemotherapy of sorafenib with transcatheter arterial infusion of cisplatin.
Sorafenib 400mg bid.
6 courses of transcatheter arterial infusion of cisplatin every 4-6 weeks

Interventions/Control_2

Sorafenib 400mg bid.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Advanced hepatocellular carcinoma with histological evidence or typical computed tomographic scans, angiographic findings and elevated serum AFP/PIVKA-II level
2) No indication for surgical resection, liver transplantation, local ablation therapy or transarterial chemoembolization
3) No prior chemotherapy
4) Aged 20-79 years old
5) HCCs in the Liver, with or with extrahepatic tumors which not affect patient's prognosis
6) ECOG Performance Status 0-1
7) Adequate organ function
a) Neutrophil>=1500 /mm3
b) Hb>= 8.5 g/dL
c) PLT>= 60000 /mm3
d) T-Bil<= 2.0 mg/dL
e) Albumin>= 2.8 g/dL
f) AST<= within 5 times of normal limit
g) ALT<= within 5 times of normal limit
h) Cre<= 1.2 mg/dl
i) Creatinin cliarance >= 60ml/min
8) Child-Pugh score 5-7 points
9) Adequate indication for hepatic arterial infusion chemotherapy
10) Interval of at least 4 weeks between last treatment and start of present treatment
11) Life expectancy of at least 8 weeks
12) Written informed consent

Key exclusion criteria

1) Refractory pleural effusion or ascites
2) Encephalopacy
3) Concurrent disease
a) Serious hypertension
b) Severe heart disease
c) Acute myocardial infarction within 6 months orior to inclusion
d) Active double cancer
e) Severe mental disorder
f) Allergic reaction to iodine contrast material
g) Severe drug allergy
4) Pregnant and lactating females; females of childbearing age unless using effective contraception
5) Inadequate for administration orally
6) Concomitant treatment with drugs inductors of CYP3A4
7) Inadequate physical condition,as diagnosed
by primary physician

Target sample size

105


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuji Okusaka

Organization

National Cancer Center Hospital

Division name

Department of Hepatobiliary and Pancreatic Oncology

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

TEL

03-3542-2511

Email

tokusaka@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Shimizu

Organization

National Cancer Center Hospital East

Division name

Department of Hepatobiliary and Pancreatic Oncology

Zip code


Address

6-5-1 Kashiwanoha Kashiwa-shi, Chiba-ken, 277-8577 Japan

TEL

0471-33-1111

Homepage URL


Email

sashimiz@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Cancer Fundation

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

国立がん研究センター中央病院(東京都),国立がん研究センター東病院(千葉県),
栃木県済生会宇都宮病院(栃木県)、神奈川県立がんセンター(神奈川県)、愛知県がんセンター(愛知県)、大阪医療センター(大阪府)、石川県立中央病院(石川県)、国立国際医療研究センター(東京都)、札幌厚生病院(北海道)、手稲渓仁会病院(北海道)、千葉県がんセンター(千葉県)、大阪市立大学医学部附属病院(大阪府)、杏林大学医学部付属病院(東京都)、金沢大学附属病院(石川県)、東京慈恵会医科大学附属病院(東京都)、近畿大学医学部附属病院(大阪府)、岡山大学病院(岡山県)、神戸大学医学部附属病院(兵庫県)、四国がんセンター(愛媛県)、京都府立医科大学附属病院(京都府)、九州がんセンター(福岡県)、がん研有明病院(東京都)、東海大学医学部付属病院(神奈川県)、東京医科大学病院(東京都)、奈良県立医科大学附属病院(奈良県)、獨協医科大学病院(栃木県)、北里大学東病院(神奈川県)、大阪府立成人病センター(大阪府)、栃木県立がんセンター(栃木県)、東京女子医科大学消化器病センター(東京都)、帝京大学医学部附属病院(東京都)、埼玉県立がんセンター(埼玉県)、静岡県立静岡がんセンター(静岡県)、横浜市立大学附属市民総合医療センター(神奈川県)、千葉大学医学部附属病院(千葉県)、福岡大学病院(福岡県)、川崎医科大学附属病院(岡山県)


Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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 04 Month 21 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date

2014 Year 12 Month 19 Day

Date of closure to data entry


Date trial data considered complete

2015 Year 01 Month 16 Day

Date analysis concluded

2015 Year 02 Month 02 Day


Other

Other related information



Management information

Registered date

2011 Year 06 Month 01 Day

Last modified on

2015 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006737


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name