UMIN-CTR Clinical Trial

Public title

Randomized phase II study comparing pegylated interferon alpha-2b combined with intra-arterial 5-fluorouracil and sorafenib alone for advanced hepatocellular carcinoma

Acronym

Comparing pegylated interferon alpha-2b combined with 5-fluorouracil and sorafenib for advanced hepatocellular carcinoma

Scientific Title

Randomized phase II study comparing pegylated interferon alpha-2b combined with intra-arterial 5-fluorouracil and sorafenib alone for advanced hepatocellular carcinoma

Scientific Title:Acronym

Comparing pegylated interferon alpha-2b combined with 5-fluorouracil and sorafenib for advanced hepatocellular carcinoma

Region

Japan

Condition

advanced hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In this study, we evaluated the efficacy of combined 5-FU and PEG-IFN alpha-2b, and compared outcomes between advanced HCC patients with PVTT treated using sorafenib.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Progression free survival

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Enrolled patients will be randomly assigned to receive combined 5-FU and PEG-IFN alpha-2b or sorafenib.
In the 5-FU and PEG-IFN alpha -2b group, after insertion of the drug delivery system, patients received arterial infusion of chemotherapeutic agents via the injection port. Patients are treated with subcutaneous administration of PEG-IFN alpha-2b (PegIntron; Schering-Plough, Osaka, Japan) and intra-arterial infusion of 5-FU (Kyowa Hakko, Tokyo, Japan). One treatment cycle lasts 4 weeks. PEG-IFN alpha-2b dose is weight-adjusted and administered subcutaneously on day 1 of every week. Administration of 5-FU (250 mg/day) into the hepatic artery for 5 h via mechanical infusion pump is performed on days 1-5 of every week.

We will compare the early response to the therapy, progression free survival (PFS) and the cumulative survival rate between these two groups for thee years.

Interventions/Control_2

In the sorafenib group, patients are treated using continuous oral treatment with 400-800 mg of sorafenib (consisting of two 100-200 mg tablets) twice daily

We will compare the early response to the therapy, progression free survival (PFS) and the cumulative survival rate between these two groups for thee years.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Eligibility criteria for treatment were as follows: 1) Portal vein tumor thrombosis (PVTT) grade Vp2-Vp4; 2) no indications for radiotherapy, surgical resection or nonsurgical interventions such as radiofrequency ablation (RFA), microwave coagulation therapy (MCT), percutaneous ethanol injection (PEI) or trans-hepatic arterial chemoembolization (TACE); 3) age >20 years; 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS)4 level 0-2; 5) no uncontrollable ascites or pleural effusion; 6) platelet count >50000/mm3, leukocyte count >2000/l, total bilirubin <3 mg/dl, and serum creatinine <1.5 mg/dl; and 7) chronic hepatitis (CH) or compensated liver cirrhosis (LC) with a Child-Pugh class of A or B.

Key exclusion criteria

Exclusion criteria for treatment were as follows:1) pregnancy women 2) patients who had allergic disorder and severe disease

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiro Kasai

Organization

Iwate Medical University

Division name

Division of gastroenterology and hepatology, Department of internal medicine,

Zip code

Address

Uchimaru 19-1, Morioka, Iwate 020-8505, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Iwate Medical University

Division name

Division of gastroenterology and hepatology, Department of internal medicine,

Zip code

Address

TEL

Homepage URL

Email

kaz-k@yc4.so-net.ne.jp

Institute

Iwate Medical University

Institute

Department

Personal name

Organization

Japanese foundation for multidisciplinary treatment of cancer

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

08

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2009

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

08

Month

17

Day

Last modified on

2012

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010235