UMIN-CTR Clinical Trial

Public title

Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma

Acronym

HICS 55

Scientific Title

Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma

Scientific Title:Acronym

HICS 55

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 followed by sorafenib for advanced hepatocellular.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The 1-year survival rate

Key secondary outcomes

The 2-year survival rate
Over all survival
Respose rate of HAIC
Survival rate according to HAIC response
Time to progression of HAIC
Response rate of sorafenib
Survival rate according to sorafenib response
Adverse events
Liver function process

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

Hepatic arterial infusion chemotherapy
(Low-Dose FP)
Patients become refractory HAIC ,
followed by sorafenib.

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) 20 Years and older.
2) Life expectancy of at least 12 weeks at the pre-treatment evaluation.
3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or MRI.
4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
5) At least 4 weeks since last therapy for HCC.
6) Patients with no sorafenib and hepatic arterial infusion chemotherapy.
7) Intrahepatic tumor which affects patient'prognosis.
8) Extrahepatic tumor apread which not affects patient's prognosis.
9) ECOG Performance status of 0 or 1.
10) Child-Pugh 5,6,7
12) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:
Granulocyte >= 3000/mm3
Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl
Total serum bilirubin <= 3 mg/dl
serum albimin>=2.8
Serum creatinine <= 1.5 mg/dl
prothrombin consumption test>=50%
Amylase <= 2 times upper limit of normal
12) Written Informed Consent must be obtained.

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 or CDDP.
7) With severe bone marrow supression.
8) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro-
intestinal bleeding.
9) Serious hypertension
10) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

Target sample size

55

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

082-257-5191

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

Date of disclosure of the study information

2012

Year

10

Month

11

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

10

Month

01

Day

Anticipated trial start date

2012

Year

10

Month

11

Day

Last follow-up date

2016

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

11

Day

Last modified on

2019

Year

04

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010200