NCT02178280

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

3.6 years

First QC Date

June 14, 2014

Last Update Submit

June 26, 2014

Conditions

Hilar Cholangiocarcinoma

Outcome Measures

Primary Outcomes (6)

  • survival rate

    1-yr survival rate

  • survival rate

    3-yr survival rate

  • survival rate

    5-yr survival rate

  • tumor-free survival rate

    1-yr tumor-free survival rate

  • tumor-free survival rate

    3-yr tumor-free survival rate

  • tumor-free survival rate

    5-yr tumor-free survival rate

Secondary Outcomes (2)

  • acute rejection rate

    usually within 2 months after liver transplantation

  • chronic rejection rate

    usually 2 months upon liver transplantation

Study Arms (2)

unresectable hilar cholangiocarcinoma

NO INTERVENTION

control group

liver transplantation

EXPERIMENTAL

liver transplantation combined with neoadjuvant radiochemotherapy

Other: liver transplantation combined with neoadjuvant therapy

Interventions

liver transplantation combined with neoadjuvant therapyOTHER

liver transplantation combined with neoadjuvant radiochemotherapy

liver transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • intrahepatic cholangiocarcinoma uncontrolled infection intrahepatic or extrahepatic metastasis distant lymph node metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatobiliary department, Nanjing DrumTower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Yitao Ding

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    STUDY CHAIR

Central Study Contacts

Yitao Ding, MD

CONTACT

86 25 83304616yitao_ding@163.com

Jinyang Gu, MD

CONTACT

86 25 83304616gjynyd@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nanjing DrumTower Hospital

Study Record Dates

First Submitted

June 14, 2014

First Posted

June 30, 2014

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

CN(1)