UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003831
Receipt number R000003001
Scientific Title A phase 1 study of a combination chemotherapy, Sorafenib and intrahepatic arterial infusion of IA-call® (DDP-H), for advanced hepatocellular carcinoma.
Date of disclosure of the study information 2010/07/01
Last modified on 2012/01/10 23:52:18

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Basic information

Public title

A phase 1 study of a combination chemotherapy, Sorafenib and intrahepatic arterial infusion of IA-call® (DDP-H), for advanced hepatocellular carcinoma.

Acronym

A combination chemotherapy of Sorafenib and DDP-H for HCC (Phase 1).

Scientific Title

A phase 1 study of a combination chemotherapy, Sorafenib and intrahepatic arterial infusion of IA-call® (DDP-H), for advanced hepatocellular carcinoma.

Scientific Title:Acronym

A combination chemotherapy of Sorafenib and DDP-H for HCC (Phase 1).

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Selection of candidate predictors for therapeutic efficacy and determination of dose-limiting toxicity, maximum tolerated dose, therapeutic dose, and a type and frequency of adverse events in combination chemotherapy with intrahepatic arterial infusion of DDP-H for patients with advanced hepatocellular carcinoma.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Dose-limiting toxicity, recommended dose, adverse events.

Key secondary outcomes

Response rate, time to progression, overall survival


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

Medicine

Interventions/Control_1

Sorafenib is administered everyday at a dose of 400mg bid one month prior to an initiation of DDP-H, which is infused to the entire liver through a hepatic artery at a rate of 3mg/min in total of 65 mg/m2. DDP-H infusion is repeated three times with an interval of 4 to 8 weeks. If dose-limiting toxicities (DLTs) are not depicted in 3 or more cases out of 5 cases, the same regimen is carried out by increasing a dose of Sorafenib to 600mg bid in everyday. If still DLTs are seen in less than 3 in 5 cases, a dose of Sorafenib is further increased to 800mg bid in everyday. If 3 or more cases has already suffered from DLTs with 400mg, Sorafenib is reduced to 400mg bid in alternative day or further 200mg sid in alternative day.

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

20 years-old <=

Age-upper limit

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histologically and/or clinically proven hepatocellular carcinoma except for mixed type.
2)Adequate for none of surgical resection, puncture-based therapies, or transhepatic arterial chemoembolization
3)There are bidimensionally measurable targets in the liver.
4)Age between 20 and 79 years old.
5)ECOG performance status score of 0-2.
6)Sufficient functional reserve of major organs.
a)Neutrophil count : 1,500 /mm3 =<
b)Platelet count: 50,000 /mm3 =<
c)Hemoglobin: 8.0 g/dL =<
d)Total bilirubin: 3.0 mg/dL =>
e)Total amylase in serum: 324 IU/bL =>
f)Creatinine clearance: 50ml/min =< (adjusted for 1.73m2 of body surface area)
7)Child-Pugh score of equal or less than 7.
8)An internal of 4 or more weeks after latest therapy against hepatocellular carcinoma.
9)A written informed consent from a patient him/her self.

Key exclusion criteria

1)Pleural effusion and/or ascites refractory to treatments.
2)Comorbidity:
a)Hyper tension over 100mmHg of diastolic blood pressure under medication.
b)Uncontrollable heart failure, angina pectoris or arrhythmia.
c)Myocardial infarction within 6 months.
d)Brain metastasis.
e)Active infectious diseases except for hepatitis.
f)Active bleeding from GI tract.
g)Active concomitant cancer with invasive nature.
h)Severe mental disorder or hepatic encephalopathy.
3)A history of severe allergic reaction against iodine contrast medium and/or platinum agents.
4)A pregnant or lactating female or female of childbearing age unless using effective contraception.
5)Ongoing interferon therapy.
6)Difficulties of oral intake.
7)Other serious conditions judged to be inadequate by a responsible doctor.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Suda

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan

TEL

025-223-2207

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hirokazu Kawai

Organization

Niigata Hepatocellular Carcinoma Therapy Study Group

Division name

Excutive office

Zip code


Address

1-757 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan

TEL

025-227-2207

Homepage URL


Email

kawaih@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata Hepatocellular Carcinoma Therapy Study Group

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

新潟大学医歯学総合病院(新潟県)


Other administrative information

Date of disclosure of the study information

2010 Year 07 Month 01 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

Terminated

Date of protocol fixation

2009 Year 10 Month 26 Day

Date of IRB


Anticipated trial start date

2009 Year 11 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 04 Month 01 Day

Date trial data considered complete

2011 Year 05 Month 01 Day

Date analysis concluded

2011 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 06 Month 28 Day

Last modified on

2012 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003001


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name