UMIN-CTR Clinical Trial

Public title

Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801)

Acronym

CCarbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis

Scientific Title

Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801)

Scientific Title:Acronym

CCarbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis

Region

Japan

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine	Radiology	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Efficacy

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Overall survival

Key secondary outcomes

Adverse event, Tumor response (response rate, disease control rate), Time-to-local progression,Progression-free survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Nakano

Organization

Gunma University

Division name

Heavy-ion Medical Center

Zip code

Address

3-39-15 Showa, Maebashi, Gunma

TEL

027-220-8378

Email

tnakano@gunma-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kei Shibuya

Organization

Gunma University

Division name

Heavy-ion Medical Center

Zip code

Address

3-39-15 Showa, Maebashi, Gunma

TEL

027-220-8378

Homepage URL

Email

shibukei@gunma-u.ac.jp

Institute

Gunma University Heavy-ion Medical Center

Institute

Department

Personal name

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2018

Year

06

Month

30

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

Preinitiation

Date of protocol fixation

2018

Year

04

Month

09

Day

Date of IRB

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

Other related information

Registered date

2018

Year

06

Month

14

Day

Last modified on

2018

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037621