Safety Study of Liver Transplantation for Hilar Cholangiocarcinoma

Hilar Cholangiocarcinoma Clinical Trial

Official title:

Phase 1 Study of Liver Transplantation Combined With Neoadjuvant Radiochemotherapy for Unresectable Hilar Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178280
• Other study ID #: 20140615
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 14, 2014
• Last updated: June 26, 2014
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2014
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Yitao Ding, MD
• Phone: 86 25 83304616
• Email: yitao_ding[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hilar Cholangiocarcinoma
• Klatskin's Tumor

Intervention

Other:
• liver transplantation combined with neoadjuvant therapy
liver transplantation combined with neoadjuvant radiochemotherapy

Locations

Country	Name	City	State
China	Hepatobiliary department, Nanjing DrumTower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate		1-yr survival rate	Yes
Primary	survival rate		3-yr survival rate	Yes
Primary	survival rate		5-yr survival rate	Yes
Primary	tumor-free survival rate		1-yr tumor-free survival rate	Yes
Primary	tumor-free survival rate		3-yr tumor-free survival rate	Yes
Primary	tumor-free survival rate		5-yr tumor-free survival rate	Yes
Secondary	acute rejection rate		usually within 2 months after liver transplantation	Yes
Secondary	chronic rejection rate		usually 2 months upon liver transplantation	Yes