UMIN-CTR Clinical Trial

Public title

A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma

Acronym

A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma

Scientific Title

A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma

Scientific Title:Acronym

A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and to determine recommended dose of combination therapy of TS-1 and sorafenib in patients with advanced hepatocellular carcinoma

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Incident of dose limiting toxcity

Key secondary outcomes

Adversed event
Response rate
Disease control rate
Time to progression
Progression free survival
Overall survival

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

The combination therapy of TS-1 and 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)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images
2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy)
3)At least 1 target lesion measurable
4)Performance status (ECOG scale): 0,1
5)Age >= 20 years
6)Adequate bone marrow, liver, renal and cardiac function as assessed by the following
(a)Neutrophil >= 1500/mm3
(b)Hemoglobin >= 9.0 g/dl
(c)Platelets >= 50000/mm3
(d)Total bilirubin < 3.0mg/dl
(e)Liver transaminases <= 10 x Upper limit of Normal(ULN)
(f)ALB >= 2.8 g/dl
(g)Cre <= ULN
(h)PT >= 40%
7)Child-pugh A
8)Patients can take food and drugs oral
9)Life expectancy of at least 12 weeks
10)Written informed consent

Key exclusion criteria

1)Previous therapy for hepatocellular carcinoma within 30days before study entry
2)Major surgery within 30 days before study entry or surgery within 15 days before study entry
3)Portal vein tumor thrombs in the main trunk
4)Uncontrollable hypertension
5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics
6)Hepatoencepharopathy. Brain lesions with clinical symptoms
7)Central nerve system tumor(including brain metastasis)
8)Bone metastasis with clinical symptoms
9)Active infection(except HBV and HCV infection)
10)Evidence of serious gastrointestinal bleeding within 30days before study entry
11)Gastro-esophazeal varices requiring preventive treatment
12)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment
13)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence)
14)Severe hypersensitivity of TS-1 or sorafenib
15)Severe complication
16)Any patients judged by the investigator to be unfit to participate in the study

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Fumihiko Kanai

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code

Address

1-8-1 Inohana, Tyuuou-ku, Chiba

TEL

043-226-2083

Email

Name of contact person

1st name
Middle name
Last name	Yoshihiko Ooka

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code

Address

1-8-1 Inohana, Tyuuou-ku, Chiba

TEL

043-226-2083

Homepage URL

Email

Institute

Chiba University Hospital

Institute

Department

Personal name

Organization

None

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

千葉大学医学部附属病院（千葉県）

Date of disclosure of the study information

2009

Year

10

Month

07

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

2009

Year

09

Month

24

Day

Date of IRB

Anticipated trial start date

2009

Year

10

Month

01

Day

Last follow-up date

2011

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

10

Month

07

Day

Last modified on

2014

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003166