UMIN-CTR Clinical Trial

Public title

Efficacy of postoperative hepatic arterial infusion chemotherapy with CDDP for hepatocellular carcioma with early recurrence risk factors.

Acronym

adjubant CDDP TAI for HCC with high recurrence risk factors.

Scientific Title

Efficacy of postoperative hepatic arterial infusion chemotherapy with CDDP for hepatocellular carcioma with early recurrence risk factors.

Scientific Title:Acronym

adjubant CDDP TAI for HCC with high recurrence risk factors.

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Medicine in general	Surgery in general	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy with CDDP, in patients with hepatocellular carcinoma with early recurrence factors.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

2 years recurrence rate

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

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

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients with curative hepatectomy
2) Patients with hepatocellular carcinoma diagnosed by histologial examination
3) Patients with early recurrence risk factors
4) Patients without recurrence
5) within 10 weeks after surgery
6) Male or female aged 20 years or older at the time of informed consent and younger than 85 years old
8) Patinets with chronic hepatitis or Child-Pugh class A, B cirrhosis
8) Patients with an ECOG Performance Status (PS) score of 0 or 1,2
9) Adequate organ function
a.Neutrophil>=3000 /mm3
b.PLT>= 50000 /mm3
c.Hb>= 8.0g/dL
d.T-Bil<= 3.0 mg/dL
e.ALB>2.5g/dl
f.AST<= within 5 times of normal limit
ALT<= within 5 times of normal limit
g.Cre<= within 1.5 times of normal limit
h.PT>=40%
i.No need of treatment on ECG
10) Life expectancy of at least 3 months
11) Patients obtained written informed consent

Key exclusion criteria

1) Patients with mixed hepatocellular and cholangiocellular carcinoma diagnosed by histologial examination
2) Severe arterio-portal or arterio-venous shunts in the liver
3) Patinets with difficulty with drug arrival to hepatic lesion
4) 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
5) Allergic reaction to iodine contrast material, gadolinium contrast material, or platium containing agent.
6)Patients medicated with steroid
7) A pregnant woman, or a woman suspected of pregnancy.
8) Patients who are concluded to be inappropriate to participate in this study by their physitians

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Kazuaki Chayama

Organization

Hiroshima University Hospital

Division name

Department of Gastroenterology and Metabolism,Department of Surgery

Zip code

Address

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

TEL

082-257-5191

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

広島大学病院（広島県）

Date of disclosure of the study information

2013

Year

10

Month

15

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

2013

Year

06

Month

27

Day

Date of IRB

2013

Year

10

Month

07

Day

Anticipated trial start date

2013

Year

10

Month

15

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

10

Month

15

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=R000013260