Treatment for Bile Duct Cancer in the Liver

Study Overview
=================
Brief Summary
-----------------
The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic cholangiocarcinoma. This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma.

Official Title
-----------------
Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study

Conditions
-----------------
Cholangio Carcinoma

Intervention / Treatment
-----------------
* Drug: SIRT Yttrium-90


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years Histological or cytological diagnosis of cholangiocarcinoma Disease not amenable to surgery Predominant disease load in the liver (in case of extra-hepatic involvement, only patients with lymph nodes metastases are allowed) Naïve to locoregional or systemic treatment (but patients who develop recurrent disease after surgery are suitable) ECOG PS 0-1 At least one measurable disease lesion according to RECIST v 1.1 Life expectancy of 12 weeks or longer Adequate hematological, renal and hepatic function Platelet ≥100 x 109 ANC ≥ 1.5 x 109 Bilirubin ≤ 30µmol/L Albumin ≥ 30g/L ALT ≤ 3 ULN INR ≤ 1.5 Serum creatinine ≤ 1.5 x ULN Exclusion Criteria: Prior malignancy except cervical carcinoma-in-situ or treated basal cell carcinoma. Any cancers treated curatively > 5 years prior to study entry are permitted. Patients with extra-hepatic disease other than regional lymph node metastases. Evidence of ascites or cirrhosis, as determined by clinical or radiologic assessment Biliary obstruction with no possibility of drainage Non-malignant disease that would render the patient unsuitable for treatment according to the protocol Prior treatment of chemotherapy for the cholangiocarcinoma Prior radiation therapy to the upper abdomen Complete thrombosis of the main portal vein Tumor volume > 50% of the normal liver volume Allergy to non-ionic contrast agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIRT<br> | Drug: SIRT Yttrium-90<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2 years | 
| Radiological response |  | 2 years | 
| disease control rate |  | 2 years | 
| Duration between timing of chemotherapy and SIRT-Y90 |  | 2 years | 
| Rate and severity of toxicities |  | 2 years | 
| Serological response in CA 19.9 |  | 2 years |