UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007267
Receipt number R000008575
Scientific Title Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma
Date of disclosure of the study information 2012/02/11
Last modified on 2022/08/23 01:18:39

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Basic information

Public title

Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma

Acronym

Efficacy of HAIC with cisplatin before RFA for HCC

Scientific Title

Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma

Scientific Title:Acronym

Efficacy of HAIC with cisplatin before RFA for HCC

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before RFA for the prevention of HCC recurrence

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Recurrence free survival

Key secondary outcomes

Incidence of adverse events
Time to treatment failure with RFA
Evaluation of treatment effect with tumor markers


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Hepatic arterial infusion chemotherapy with cisplatin and RFA

Interventions/Control_2

RFA

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients with hepatocellular carcinoma diagnosed by histologial examination or by imaging modalities
2) Less than or equal to 3 lesions, 30 mm or less in diameter
3) No extra-hepatic metastasis
4) No vascular invasion
5) Patients in Child-Pugh Class A or B
6) Male or female aged 20 years or older at the time of informed consent and younger than 90 years old
7) Patients with an ECOG Performance Status (PS) score of 0 or 1
8) No prior chemotherapy
9) Adequate organ function
a) Neutrophil>=1500 /mm3
b) Hb>= 8.5 g/dL
c) PLT>= 50000 /mm3
d) T-Bil<= 2.0 mg/dL
e) AST<= within 5 times of normal limit
ALT<= within 5 times of normal limit
f) Cre<= within 1.5 times of normal limit
10) Written informed consent
11) Life expectancy of at least 6 months

Key exclusion criteria

1) Patients with histologically diagnosed mixed hepatocellular carcinoma or sarcomatoid carcinoma
2) History of any therapy to hepatocellular carcinoma
3) Patients unsuitable for RFA
4) Patients unsuitable for administration of CDDP
5) Patients who have simultaneous malignancies
6) Patients who have severe complications
7) Ascites or pleural effusion unresponsible to therapy
8) Patients inadequate in the investigator's judgement

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Kazuhide
Middle name
Last name Yamamoto

Organization

Okayama university graduate school of medicine, dentistry, and pharmaceutical sciences

Division name

Department of gastroenterology and hepatology

Zip code

7008558

Address

2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture

TEL

090-235-7219

Email

kazuhide@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Nouso

Organization

Okayama university hospital

Division name

Department of gastroenterology

Zip code

7008558

Address

2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture

TEL

086-235-7219

Homepage URL


Email

nouso@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Gastroenterology, Okayama City Hospital, Okayama, Japan
Medical Center for Clinical and Translational Research, Hiroshima University Hospital, Hiroshima, Japan
Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan
Department of Internal Medicine, Fukuyama City Hospital, Hiroshima, Japan
Department of Internal Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan
Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Okayama university graduate school of medicine, dentistry, and pharmaceutical sciences, ethics committee

Address

2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture

Tel

086-235-6762

Email

MAE6605@adm.okayama-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

岡山大学病院(岡山県)
広島市民病院(広島県)
岡山市民病院(岡山県)
福山市民病院(広島県)
岡山赤十字病院(岡山県)
三豊総合病院(香川県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 11 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/33687130/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33687130/

Number of participants that the trial has enrolled

74

Results

Recurrence-free survival rates at 1 (3) year in the HAIC group and non-HAIC group were 82.9% (54.3%) and 74.3% (34.3%), respectively (hazard ratio [HR], 0.597; 95% confidence interval [CI], 0.320-1.091; p = 0.094]. Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022).

Results date posted

2022 Year 08 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 03 Month 29 Day

Baseline Characteristics

Patients with naive early stage HCC diagnosed between August 2012 and July 2016 were recruited. All authors had access to the study data, and reviewed and approved the final manuscript.

Participant flow

After confirming the fulfillment of the eligibility criteria, the investigators registered the patients using a Web based system. The patients were then randomly assigned to receive either HAIC before RFA therapy (HAIC group) or RFA monotherapy (non HAIC group) in a 1 to 1 ratio. Allocation of the treatment group was performed with hos- pitals, tumor size, tumor number, and performance status as stratification factors. Patients were blinded to treatment allocation, although the investigators who conducted the HAIC therapy could not be blinded.

Adverse events

none

Outcome measures

Progression free survival
Time to untreatable progression
Adverse events
Changes of tumor markers

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2012 Year 01 Month 24 Day

Date of IRB

2012 Year 01 Month 24 Day

Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 02 Month 11 Day

Last modified on

2022 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008575


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name