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Safety Study of Liver Transplantation for Hilar Cholangiocarcinoma

NCT ID: NCT02178280

Last Updated: 2014-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-12-31

Brief Summary

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Hilar cholangiocarcinoma is a highly malignant tumor. Surgical resection or simple liver transplantation leads to poor prognosis accompanied by high recurrence rate and low survival rate. The newly proposed neoadjuvant therapy with liver transplantation strategy shows promising clinical application, which once reported 5-year survival rate 82%. However, transplantation centers conducting this kind of research are limited due to its complexity and long-term. The investigators would like to conduct a clinical trial for only unresectable hilar cholangiocarcinoma patients who should take neoadjuvant brachytherapy and chemoradiotherapy followed by orthotopic liver transplantation.

Detailed Description

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The enrolled patients should be prescribed with several examinations when admitted to hospital consisting of CT, MRI, MRCP, ECT, PET/CT and other laboratory tests. All preoperative examinations must indicate that enrolled individuals should be diagnosed as unresectable hilar cholangiocarcinoma. In addition, repetitive ERCP manipulations are needed in order to obtain positive results by brush cytology. Of course, all enrolled patients should be adherent to the fundamental principles of liver transplantation.

We employed I-125 radioactive plastic stents (patent No: ZL 201610116321.3) to conduct brachytherapy. Each stent composed of a drainage tube with a stab at both ends that had a stabilizing effect. Two opposite channels were made in the wall of stents paralleling the drainage lumen, with irradiation window in the lateral wall of the channel. The diameter of the channel is a bit smaller than that of the radioactive seeds, so as is the length and width of irradiation windows. The stents are so designed to immobilize seeds and radiate properly. The radioactive I-125 seeds were 4.5 mm long and 0.8 mm thick, and their half-life was 60.1 days. The nasobiliary radiography was performed to determine the length of involvement of bile duct.Corresponding radioactive seeds are then put in appropriate location with biliary stents by ERCP procedure.

About a month later, external beam radiotherapy was administrated to a target dose of 30Gy in 30 fractions, 1.5Gy twice per day. Concomitantly, Intravenous capecitabine was given at 1.0g bid for two weeks, which is repeated after 14 days until transplantation.

Immunosuppressive therapy was provided with tacrolimus, mycophenolate and corticosteroids. Corticosteroids were withdrawn a week later. Chemotherapy was continued 1 month after OLT with expected 3 courses.

Conditions

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Hilar Cholangiocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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unresectable hilar cholangiocarcinoma

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

liver transplantation

liver transplantation combined with neoadjuvant radiochemotherapy

Group Type EXPERIMENTAL

liver transplantation combined with neoadjuvant therapy

Intervention Type OTHER

liver transplantation combined with neoadjuvant radiochemotherapy

Interventions

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liver transplantation combined with neoadjuvant therapy

liver transplantation combined with neoadjuvant radiochemotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

unresectable hilar cholangiocarcinoma tumor diameter less than 3 cm adherence to liver transplantation requirements

Exclusion Criteria

intrahepatic cholangiocarcinoma uncontrolled infection intrahepatic or extrahepatic metastasis distant lymph node metastasis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Ding Yitao

Nanjing DrumTower Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yitao Ding

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

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Hepatobiliary department, Nanjing DrumTower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yitao Ding, MD

Role: CONTACT

Phone: 86 25 83304616

Email: [email protected]

Jinyang Gu, MD

Role: CONTACT

Phone: 86 25 83304616

Email: [email protected]

Facility Contacts

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Yitao Ding, MD

Role: primary

Jinyang Gu, MD

Role: backup

Other Identifiers

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20140615

Identifier Type: -

Identifier Source: org_study_id