UMIN-CTR Clinical Trial

Public title

Evaluation of conversion rate after transarterial chemoemobolization using for unresectable hepatocellular carcinoma

Acronym

Conversion rate after CDDP-TACE for unresectable HCC

Scientific Title

Evaluation of conversion rate after transarterial chemoemobolization using for unresectable hepatocellular carcinoma

Scientific Title:Acronym

Conversion rate after CDDP-TACE for unresectable HCC

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the conversion rate for salvage surgery after transarterial chemoemobolization (TACE) using cisplatin (CDDP) for advanced unresectable hepatocellular carcinoma

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Conversion rate for salvage surgery

Key secondary outcomes

Response rate for TACE, Time to progression (TTP), Overall survival (OS), disease-free survival time after salvage hepatectomy, completion rate, safty & adverse event

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

Maneuver

Interventions/Control_1

Transarterial chemoembolization using cisplatin (CDDP-TACE),
Liver resection

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) Histologically or clinical diagnosed hepatocellular carcinoma
2) A proper indication for TACE without indication of surgery or ablation therapy
3) 20 years old and more
4) Performance status (ECOG) 0 or 1
5) life expectantcy of at least 6 months
6) Child-pugh A or B
7) Satisfying following blood test before registration
WBC >=2,000/micro litter
Neu >=1,000/micro litter
Hb >= 8.5g/dL
Platelet >=70,000 /micro litter
Total bilirubin <=1.5 mg/dl
AST [GOT] <= 150 IU/L
ALT [GPT] <= 150 IU/L
Creatinine <= 1.2 mg/dL
8) Primary cases or recurrence cases after hepatectomy or RFA
9) Agreement to be enrolled in a form of informed consent

Key exclusion criteria

1) Patologically diagnosed as combined hepatocellular and cholangiocellular carcinoma
2) Extrahepatic metastasis
3) Vascular involvement Vp3 or more
4) Hepatic encephalopathy
5) Active infection except for HBV and HCV
6) Severee complications
7) acitve double cancer
8) Pregnant, possibility of pregnancy, or feeding a baby Pregnancy
9) Medication that may affect to the absorption of drug or pharmacokinetics
10) Other factors that a responsible doctor judged to be unsuitable

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hiroaki Nagano

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Surgery

Zip code

Address

2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan

TEL

06-6879-3251

Email

hnagano@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Wada

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Surgery

Zip code

Address

2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan

TEL

06-6879-3251

Homepage URL

Email

hwada98@gesurg.med.osaka-u.ac.jp

Institute

Multicenter Clinical Study Group of Osaka

Institute

Department

Personal name

Organization

Non

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

2014

Year

06

Month

13

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

2013

Year

06

Month

13

Day

Date of IRB

Anticipated trial start date

2014

Year

06

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

06

Month

12

Day

Last modified on

2015

Year

07

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016601