UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030739
Receipt number R000035104
Scientific Title Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial
Date of disclosure of the study information 2018/01/09
Last modified on 2018/01/09 19:54:52

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Basic information

Public title

Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial

Acronym

Preoperative chemotherapy for resectable UICC7 StageIII HCC

Scientific Title

Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial

Scientific Title:Acronym

Preoperative chemotherapy for resectable UICC7 StageIII HCC

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To analyze survival benefit of preoperative chemotherapy for in patients with resectable UICC StageIIIA, IIIB advanced hepatocellular carcinoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

The 3 years disease free survival rate after liver surgery

Key secondary outcomes

Overall survival, disease free survival, response to the preoperative chemotherapy, incidence and degree of side effects of preoperative chemotherapy


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

As a preoperative chemotherapy, hepatic arterial infusion chemotherapy (HAIC) is performed, regimen of HAIC is New FP therapy. Angiography is performed on Day 1 as induction New FP and bolus injection is performed by suspending Lipiodol at a maximum of 10 ml and CDDP at a maximum of 50 mg according to the tumor diameter. Lastly, infuser pump containing 1250 mg of 5-FU is connected and administered continuously from Day 1 to Day 5, this is taken as one course. After the introduction therapy by completing the second course from Day 8 and the third course from Day 15 (for the case where tumor vascular embolism is insufficient at the end of 3 courses, the 4th course from day 22 is conducted and the introduction chemotherapy is terminated ).
New FP maintenance chemotherapy suspends CDDP up to 35 mg for Lipiodol maximum of 5 ml on Day 1 and terminates bolus injection at the time when whole tumor is filled with Lipiodol under angiography or when Lipiodol stagnates in tumor blood vessel . Continuous administration of infuser pump containing 1000 mg of 5-FU, continuous administration from Day 1 to Day 3, this is taken as one course. Maintain total of 3-4 courses with biweekly chemotherapy and complete preoperative chemotherapy. If there was a feeding artery other than the hepatic artery existed, TACE is added.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) A case of aged> or =20 years old.
2) Cases of UICC7 StageIIIA, IIIB diagnosed as hepatocellular carcinoma histologically or clinically (imaging diagnosis, tumor marker).
3) Cases of UICC7 StageIIIA, IIIB which can initially perform R0 resection at diagnosis.
4) Cases in which patient consent was obtained in the document after adequate explanation by the attending physician.
5) Patients who can expect survival for more than 3 months.
6) ECOG performance status 0 or 1.
7) Patients who had been preserved adequate major organ functions within 2 weeks before registration (bone marrow, heart, liver, kidney, etc.).
Neutrophils> or =1000/mm3
Hb> or =8.5 g/dl
Platelet> or =75,000/mm3
AST and ALT< or =200 IU/L
Child-Pugh score 7 points or less
Total bilirubin 3 mg/dl or less (Excluded after reduction of jaundice cases due to bile duct tumor obstructions)
No refractory ascites or hepatic encephalopathy
Other major organ functions are well preserved

Key exclusion criteria

1) Patients with history of advanced cancer in other organs within 5 years.
2) A patient who has history of chemotherapy of a regimen including CDDP or 5-FU.
2) Active infectious diseases (except for viral hepatitis)
3) Patients who have a history of allergy to iodine contrast agent, platinum-containing drug, or gelatin-containing drug / food.
4) Pregnant women, breast-feeding women and patients who may be pregnant.
Patients who are determined by the attending physician to be inappropriate for this examination for other reasons (in cases where the patient does not obey the instructions or has problems with family cooperation etc.).

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Okuda

Organization

Kurume University

Division name

Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery

Zip code


Address

67 Asahi-machi, Kurume-shi, Fukuoka, Japan

TEL

0942-31-7567

Email

kook@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Goto

Organization

Kurume University

Division name

Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery

Zip code


Address

67 Asahi-machi, Kurume-shi, Fukuoka, Japan

TEL

0942-31-7567

Homepage URL


Email

gotou_yuuichi@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University, Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2016 Year 10 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 09 Day

Last modified on

2018 Year 01 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name