UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801)
Title of the study (Brief title)	CCarbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Adverse event, Tumor response (response rate, disease control rate), Time-to-local progression,Progression-free survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Carbon ion raidiotherapy 60Gy(RBE)/12fr./3 weeks Hepatic arterial infusion chemotherapy (HAIC) day 1: cisplatin 20mg/body + 5FU 250mg/body day 2-5: cisplatin 10mg/body + 5FU 250mg/body A total of 2-4 courses before and after C-ion RT (not concurrently)
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) Histologically or clinically diagnosed hepatocellular carcinoma. 2) Unfit for resection or liver transplantation 3) Unfit for percutaneous tumor ablation 4) Patients untreated by previous systemic chemotherapy or cisplatin-based transarterial therapy. 5) Patients without previous treatment within four weeks 6) Patients with major portal vein and/or hepatic vein invasion. 7) Patients without extrahepatic metasitasis 8) The maximum tumor is measurable and tumor size is less than 12 cm 9) Patients without direct tumor invasion to adjacent organs 10) ECOG PS: 0-1 11) Child-Pugh score of the patient is from 5 points to 9 points. 12) Absence of uncontrolled ascites and/or pleural effusion. 13) Clinical laboratory data is fulfilled with the criteria 14) 20-year-old or older. 15) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria	1) Unfit for hepatic arterial reservoir implantation 2) Active or severe gastro-esophageal varix or bleeding 3) Patients on anti-platelet or anti-coagulation therapy 4) A history of severe allergic reaction to contrast medium or local anesthesia. 5) A history of radiation hypersensitivity 6) Patients with severe co-morbidity
Target sample size	21

Research contact person
Name of lead principal investigator	Takashi Nakano
Organization	Gunma University
Division name	Heavy-ion Medical Center
Address	3-39-15 Showa, Maebashi, Gunma
TEL	027-220-8378
Email	tnakano@gunma-u.ac.jp

Public contact
Name of contact person	Kei Shibuya
Organization	Gunma University
Division name	Heavy-ion Medical Center
Address	3-39-15 Showa, Maebashi, Gunma
TEL	027-220-8378
Homepage URL
Email	shibukei@gunma-u.ac.jp

Sponsor
Institute	Gunma University Heavy-ion Medical Center
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 06 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 09 Day
Anticipated trial start date	2018 Year 06 Month 30 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 06 Month 14 Day
Last modified on	2018 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037621