Clinical trial NCT02167711: Treatment for Bile Duct Cancer in the Liver
Official title: Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangio Carcinoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Radiological response
timeFrame: 2 years
measure: disease control rate
timeFrame: 2 years
measure: Duration between timing of chemotherapy and SIRT-Y90
timeFrame: 2 years
measure: Rate and severity of toxicities
timeFrame: 2 years
measure: Serological response in CA 19.9
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, The Chinese University of Hong Kong
name: Stephen L Chan, FRCP
role: PRINCIPAL_INVESTIGATOR
References: