UMIN-CTR Clinical Trial

Public title

pilot study of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.

Acronym

TS-1/IFN for HCC patients with metastases who do not response to TS-1/CDDP

Scientific Title

pilot study of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.

Scientific Title:Acronym

TS-1/IFN for HCC patients with metastases who do not response to TS-1/CDDP

Region

Japan

Condition

hepatocellular carcinoma with extrahepatic metastases

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To elucidate the efficacy of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

response rate

Key secondary outcomes

1) overall survival
2) time to progression
3) safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Two weeks represented one cycle of treatment. In each cycle, S-1 was administered orally at a dose of 80-120 mg daily (depending on body surface area: <1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; &#8805;1.5 m2, 120 mg), and CDDP was administered intravenously at a dose of 60 mg/m2 on day 8. Each treatment cycle was followed by a two-to-four-week rest period of no treatment.
Treatment was repeatec unless HCC reveales progressive disease (acording to RECIST).

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Diagnosis of HCC was confirmed histopathologically or clinically.
2) no adaptation of resection, liver transplantation and local abration.
3) with extrahepatic metastases
4) without uncontrollable ascites
5) without hepatic coma
6) without vascular invasion of HCC
7) PS 0-1
8) chronic hepatitis or Child-Pugh A or B
9)
WBC > 3000/mm3
Plt > 80000/mm3
Hb > 10.0 g/dl
Total Bilirubin < 2.0 mg/dl
Albumin > 3 g/dl
Creatine < 1.2mg/dl
Prothromin time > 60 percentage

Key exclusion criteria

1) With other malignant disease.
2) A pregnant woman, or a woman suspected of pregnancy.
3) With severe infectious disease.
4) With history of severe allergy.
5) With severe renal function disease. 6) With severe allergy for 5FU, TS-1 or IFN.
7) With severe bone marrow supression.
8) With pulmonary fibrosis.
9) With another fluoropyrimidine
10)With flucytosine
9) with shosaikoto
10) with autoimmune hepatitis

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Kazuaki Chayama

Organization

Hiroshima University

Division name

Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical Sciences

Zip code

Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Hiroshima University

Division name

Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Bio

Zip code

Address

TEL

Homepage URL

Email

Institute

Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University

Institute

Department

Personal name

Organization

Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University

Organization

Division

Category of Funding Organization

Self funding

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

2009

Year

12

Month

22

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

Terminated

Date of protocol fixation

2009

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

09

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

12

Month

22

Day

Last modified on

2013

Year

07

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002881