UMIN-CTR Clinical Trial

Public title

pilot study of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma patients in Child-Pugh score 8,9

Acronym

Efficacy of TAI with cisplatin for HCC in Child-Pugh score8,9

Scientific Title

pilot study of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma patients in Child-Pugh score 8,9

Scientific Title:Acronym

Efficacy of TAI with cisplatin for HCC in Child-Pugh score8,9

Region

Japan

Condition

advanced hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To elucidate the efficacy of hepatic arterial infusion chemotherapy with cisplatin for unresectable advanced hepatocellular carcinoma, and to evaluate safety and tumor response with this therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

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

Hepatic arterial infusion chemotherapy with cisplatin

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

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients with hepatocellular carcinoma diagnosed by histologial examination or by imaging modalities
2) no adaptation or no response of resection, liver transplantation and local abration,TACE,HAIC
3) Male or female aged 20 years or older at the time of informed consent and younger than 90 years old
4) Convalescence decided by hepatic leision
5) At least 1 target lesion measurable by RECIST/Modified RECIST
6) Interval of 4 weeks or over between last treatment and present therapy
7) Patients with an ECOG Performance Status (PS) score of 0 or 1,2
8) Patients in Child-Pugh score 8or 9
9) Adequate organ function
a) Neutrophil>=1500 /mm3
b)PLT>= 50000 /mm3
c) Hb>= 8.0g/dL
d) T-Bil<= 5.0 mg/dL
e) AST<= within 5 times of normal limit
ALT<= within 5 times of normal limit
f) Cre<= within 1.5 times of normal limit
g) PT>=40%
h) No need of treatment on ECG
10) Life expectancy of at least 3 months
11) Patients obtained written informed consent

Key exclusion criteria

1) Severe arterio-portal or arterio-venous shunts in the liver
2) Patinets with difficulty with drug arrival to hepatic lesion
3) Other uncontrolled severe illness.
a) With severe cardiac failure
b) With severe renal function disease
c) With active infectious disease except viral hepatitis.
d) With active gastrointestinal hemorrhage
e) With active other malignancies.
f) With hepatic encephalopathy and severe mental disorder
g) With clinically significant refractory ascites or pleural effusion
4) Allergic reaction to iodine contrast material, gadolinium contrast material, or platium containing agent.
5) A pregnant woman, or a woman suspected of pregnancy.
6) Patients who are concluded to be inappropriate to participate in this study by their physitians

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kazuaki Chayama

Organization

Hiroshima University Hospital

Division name

Department of Gastroenterology and Metabolism

Zip code

Address

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

TEL

082-257-5555

Email

chayama@hiroshima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Aikata

Organization

Hiroshima University Hospital

Division name

Department of Gastroenterology and Metabolism

Zip code

Address

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

TEL

082-257-5191

Homepage URL

Email

aikata@hiroshima-u.ac.jp

Institute

Department of Gastroenterology and Metabolism,Hiroshima University Hospital

Institute

Department

Personal name

Organization

Department of Gastroenterology and Metabolism,Hiroshima University Hospital

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

2012

Year

11

Month

06

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

Completed

Date of protocol fixation

2012

Year

10

Month

01

Day

Date of IRB

2012

Year

11

Month

02

Day

Anticipated trial start date

2012

Year

11

Month

02

Day

Last follow-up date

2017

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

06

Day

Last modified on

2019

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010511