UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049785
Receipt number R000055661
Scientific Title Living donor liver transplantation for non-resectable colorectal liver metastases
Date of disclosure of the study information 2023/04/01
Last modified on 2023/12/14 10:39:08

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Basic information

Public title

Living donor liver transplantation for non-resectable colorectal liver metastases

Acronym

Living donor liver transplantation for non-resectable colorectal liver metastases

Scientific Title

Living donor liver transplantation for non-resectable colorectal liver metastases

Scientific Title:Acronym

Living donor liver transplantation for non-resectable colorectal liver metastases

Region

Japan


Condition

Condition

non-resectable colorectal liver metastases

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Efficacy and safety of living donor liver transplantation for non-resectable colorectal liver metastases

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3 year Overall survival

Key secondary outcomes



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

living donor liver transplantation

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

18 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. histological evidence of colorectal adenocarcinoma
2. Genetic testing for cancer (RAS, BRAFV600E, MSI, mismatch repair genes, etc.) must have been performed.
3. The primary colorectal cancer has been curatively resected.
4. the metastatic disease must be considered as surgically unresectable. Liver metastases are not limited to first occurrence, but include those after hepatectomy.
5. The metastases must be located in liver only by imaging diagnosis.
6. No history of distant metastasis other than liver metastasis. Exceptions: Patients with no more than 3 lung metastases and no recurrence for more than 6 months after treatment of lung metastases are eligible.
7.Patients must have received chemotherapy for unresectable liver metastases. The duration of chemotherapy should be at least 3 months, and the regimen should be within the standard of care according to the colorectal cancer guidelines.
8. Patients must be at least 18 years old.

Key exclusion criteria

1. patients who have undergone chemotherapy and are judged to have progressed (PD).
2. an infectious disease requiring treatment
3. pregnant or possibly pregnant.
4. Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
5. Other cases that are considered not appropriate for usual living donor liver transplantation

Target sample size

23


Research contact person

Name of lead principal investigator

1st name Etsuro
Middle name
Last name Hatano

Organization

Kyoto University

Division name

Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery

Zip code

606-8507

Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto city

TEL

075-751-3242

Email

etsu@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Ken
Middle name
Last name Fukumitsu

Organization

Kyoto University

Division name

Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery

Zip code

606-8507

Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto city

TEL

075-751-3242

Homepage URL


Email

tsurugi@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Konoe-cho, Yoshida, Sakyo-ku, Kyoto-city

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


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

2023 Year 04 Month 01 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

2022 Year 12 Month 14 Day

Date of IRB

2022 Year 12 Month 12 Day

Anticipated trial start date

2023 Year 09 Month 25 Day

Last follow-up date

2032 Year 09 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 12 Month 14 Day

Last modified on

2023 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name