UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial
Title of the study (Brief title)	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	Koji Okuda
Organization	Kurume University
Division name	Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery
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	Yuichi Goto
Organization	Kurume University
Division name	Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery
Address	67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL	0942-31-7567
Homepage URL
Email	gotou_yuuichi@med.kurume-u.ac.jp

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

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035104