UMIN-CTR Clinical Trial

Public title

Randomized phase II study comparing transcatheter arterial chemo-embolization with Miriplatin and transcatheter arterial chemo-embolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma

Acronym

Comparing TACE with Miriplatin and TACE with DDPH for hepatocellular carcinoma

Scientific Title

Randomized phase II study comparing transcatheter arterial chemo-embolization with Miriplatin and transcatheter arterial chemo-embolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma

Scientific Title:Acronym

Comparing TACE with Miriplatin and TACE with DDPH for hepatocellular carcinoma

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We will evaluate and compare the efficacy of transcatheter arterial chemoembolization (TACE) using a Miriplatin and TACE using a suspension of a fine-powder formulation of cisplatin (DDPH) for hepatocellular carcinoma (HCC).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary efficacy endpoint of the current study is the objective response rate.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Miriplatin-TACE group
We used Miriplatin(Miripla, Dainippon-Sumitomo Pharmaceutical Co. Ltd., Osaka, Japan) mixed with LPD (iodized oil; Andre Guerget, Aulnay-sous-Bois, France).
The Miriplatin-LPD suspension was prepared by mixing 70 mg of DDPH into 3-10 mL of LPD.
The dosage of LPD and the anticancer drugs was adjusted depending on the tumor size, number of tumors, degree of liver impairment and renal function, however, the maximum dose of LPD was not allowed to exceed 10 mL.
Hepatic arteriography, superior mesenteric arterial porto-venography, CT during arteriography and CT during arterio-portography were performed to define the size and locations of tumor nodules and to exclude tumor thrombus in the main trunk of portal vein. Following hepatic angiography, a catheter was selectively inserted into the hepatic artery supplying the target tumor and the Miriplatin-LPD suspension was injected. In patients with several tumors in the liver, superselective catheterization was performed for each lesion. If superselective catheterization was not possible, the Miriplatin-LPD suspension was injected into the right and left main hepatic artery distal to the origin of the cystic artery. After the injection, arterioembolization was performed used a gelatin sponge particles (Gelpart; Nipponkayaku, Tokyo, Japan) mixed with contrast medium.

Interventions/Control_2

DDPH-TACE group
We used DDPH(IA-call; Nipponkayaku, Tokyo, Japan) mixed with LPD (iodized oil; Andre Guerget, Aulnay-sous-Bois, France).
The DDPH-LPD suspension was prepared by mixing 50 mg of DDPH into 3-10 mL of LPD.
The dosage of LPD and the anticancer drugs was adjusted depending on the tumor size, number of tumors, degree of liver impairment and renal function, however, the maximum dose of LPD was not allowed to exceed 10 mL.
Hepatic arteriography, superior mesenteric arterial porto-venography, CT during arteriography and CT during arterio-portography were performed to define the size and locations of tumor nodules and to exclude tumor thrombus in the main trunk of portal vein. Following hepatic angiography, a catheter was selectively inserted into the hepatic artery supplying the target tumor and the DDPH-LPD suspension was injected. In patients with several tumors in the liver, superselective catheterization was performed for each lesion. If superselective catheterization was not possible, the DDPH-LPD suspension was injected into the right and left main hepatic artery distal to the origin of the cystic artery. After the injection, arterioembolization was performed used a gelatin sponge particles (Gelpart; Nipponkayaku, Tokyo, Japan) mixed with contrast medium.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Eligibility criteria
1) No indication for surgical resection or local ablation therapy such as RFA and PEI therapy; 2) No evidence of extra hepatic metastasis; 3) No tumor thrombus in the main trunk of portal vein. 4) No evidence of active heart or renal diseases meeting the contraindications for ADM and CDDP therapy, respectively; 5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) [22] level 0-2; 6) Hypervascular tumors showing enhancement during angiography; 7) Bidimensionally measurable hepatic lesions; 8) No uncontrolled ascites or pleural effusion; 9) Total serum bilirubin (T-Bil) less than 3 mg/dL.

Key exclusion criteria

Exclusion criteria
1) Pregnancy woman
2) Patients who had allergic and severe disease

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiro Kasai

Organization

Iwate Medical University

Division name

Division of gastroenterology and hepatology, Department of internal medicine

Zip code

Address

Uchimaru 19-1, Morioka, Iwate 020-8505, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Iwate Medical University

Division name

Division of gastroenterology and hepatology, Department of internal medicine

Zip code

Address

TEL

Homepage URL

Email

Institute

Iwate Medical University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

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

08

Month

18

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

Open public recruiting

Date of protocol fixation

2010

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

08

Month

18

Day

Last modified on

2012

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010243