UMIN-CTR Clinical Trial

Public title

Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study

Acronym

HCC-CDDP+Lipiodol-P2

Scientific Title

Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study

Scientific Title:Acronym

HCC-CDDP+Lipiodol-P2

Region

Japan

Condition

HCC

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of the transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil in patients with advanced HCC who are not candidates for surgical resection, percutaneous ablation, or TACE.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate (RR)

Key secondary outcomes

Safty
Tumor markers
Overall survival (OS)
6-months survival rate
1-year survival rate
Progression free survival (PFS)

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

Transcatheter arterial chemothherapy using CDDP powder and iodized-oil.

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)Patients with typical HCC diagnosed by histological or clinical examinations.
2)Patients without candidate for hepatectomy, ablation therapy, and TACE.
3)BCLC stage B or C.
4)Child-Pugh score of 8 or less.
5)Patients aged 20 years or over.
6)ECOG performance status of 0-2.
7)Patients with measurable target lesion on Modified RECIST.
8)Patients with at least 4 weeks interval from previous hepatectomy, ablation therapy, and TACE.
9)The function of the major organ is kept as satisfied, and laboratory values meet the following criteria within 14 days before study entry.
1.White blood cell >= 3,000/mm3
2.Platelet >= 50,000/uL
3.Hemogrobin >= 8.0g/dL
4.Total serum bilirubin =< 2.0mg/dL
5.AST and ALT =< 5 times upper limits of normal
6.Prothrombin time(%) >= 50%
7.Serum creatinine =< 1.5mg/dL
8.No abnormal findings requiring treatment in the electrocardiogram
10)Patients who are expected to live more than 3 months.
11)Patients who signed the informed consent to participate in this study.

Key exclusion criteria

1)History of previous treatment by platinum drugs.
2)Extrahepatic metastasis.
3)Advanced vascular or biliary invasion (Vp4,Vv3,B3,B4).
4)Sever arterio-portal shunt or arterio-venous shunt.
5)Difficult to perform transcatheter arterial chemotherapy.
6)History of the biliary tract reconstruction or treatment.
7)Patients with following severe complicating disease(except chronic hepatitis and liver cirrhosis).
1.Heart failure
2.Renal failure
3.Active infections(except viral hepatitis)
4.Active gastrointestinal bleeding
5.Active duplicative cancer
6.Hepatic encephalopathy or severe mental illness
8)Fever >= 38.0 degrees Celsius.
9)History of hypersensitivity to iodine-containing contrast agent, gadolinium-containing contrast agent, and platinum-containing drug.
10)Patients who are pregnant, lactating, suspected to be pregnant, or wish to become pregnant.
11)Patients who are concluded to be inappropriate to participate in this study by their physicians.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Haruyuki Takaki

Organization

Mie University School of Medicine

Division name

Department of Radiology

Zip code

Address

2-174, Edobashi, Tsu, Mie

TEL

059-231-5029

Email

takaki-h@clin.medic.mie-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Haruyuki Takaki

Organization

Mie University School of Medicine

Division name

Department of Radiology

Zip code

Address

2-174, Edobashi, Tsu, Mie

TEL

059-231-5029

Homepage URL

Email

takaki-h@clin.medic.mie-u.ac.jp

Institute

Japan Society of Transcatheter Hepatic Arterial Embolization Clinical Reserch Group

Institute

Department

Personal name

Organization

Japan Society of Transcatheter Hepatic Arterial Embolization Clinical Reserch Group

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

2011

Year

04

Month

25

Day

URL releasing protocol

Publication of results

Published

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

2011

Year

02

Month

07

Day

Date of IRB

Anticipated trial start date

2011

Year

05

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

2011

Year

04

Month

24

Day

Last modified on

2015

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006503