UMIN-CTR Clinical Trial

Public title

Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib versus sorafenib alone in advanced hepatocellular carcinoma

Acronym

SCOOP-2 trial

Scientific Title

Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib versus sorafenib alone in advanced hepatocellular carcinoma

Scientific Title:Acronym

SCOOP-2 trial

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of prior transcatheter arterial infusion chemotherapy using cisplatin powder in patients with advanced HCC who are candidates for sorafenib treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

1-year survival

Key secondary outcomes

overall survival, 2-year survival, time to progression, response rate, safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sorafenib

Interventions/Control_2

Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib

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 a fine-powder formulation of cisplatin therapy.
7) Intrahepatic tumor which affects patient'prognosis.
8) Extrahepatic tumor apread which not affects patient's prognosis.
9)Adequate indication for fine-puwder formulation of cisplatin therapy.
10) ECOG Performance status of 0 or 1.
11) Cirrhotic status of Child-Pugh score 5-7.
12) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:
Granulocyte >= 1000/mm3
Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl
Total serum bilirubin <= 3 mg/dl
AST and ALT <= 5 times upper limit of normal
Serum creatinine <= 1.5 mg/dl
Amylase <= 2 times upper limit of normal
13) Written Informed Consent must be obtained.

Key exclusion criteria

1) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro-
intestinal bleeding.
2) Clinically uncontrolled ascites or pleural effusion.
3) Existing of hepatic encephalopathy
4) Serious hypertension.
5) Preexisting of history with severe coronary or cerebral artery diseases.
6) Renal failure.
7) Patients who are pregnant, suspected to be pregnant, or wish to become pregnant.
8) Risk of allergic reactions to the study drugs.
9) Active duplicative cancer
10) Previous malignancy
11) 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

90

Name of lead principal investigator

1st name
Middle name
Last name	Katsuaki Tanaka

Organization

Yokohama City University Medical Center

Division name

Gastroenterlogical Center

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

k_tanaka@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Masaaki Kondo

Organization

Yokohama City University Medical Center

Division name

Gastroenterlogical Center

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL

Email

mkondou@yokohama-cu.ac.jp

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

The Waksman Foundation of Japan

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

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

横浜市立大学附属市民総合医療センター（神奈川県）
神奈川県立がんセンター（神奈川県）
聖マリアンナ医科大学病院（神奈川県）
川崎市立多摩病院（神奈川県）
聖マリアンナ医科大学横浜市西部病院（神奈川県）
北里大学東病院（神奈川県）
広島大学病院（広島県）
伊勢崎市民病院（群馬県）

Date of disclosure of the study information

2011

Year

08

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

2011

Year

07

Month

22

Day

Date of IRB

Anticipated trial start date

2011

Year

08

Month

01

Day

Last follow-up date

2016

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

08

Month

11

Day

Last modified on

2017

Year

02

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007270