Treatment for Bile Duct Cancer in the Liver

Phase 2

Completed

• Conditions: Cholangio Carcinoma
• Interventions: Drug: SIRT Yttrium-90

• Registration Number: NCT02167711
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-19
• Study Start: 2014-09-17
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIRT	SIRT Yttrium-90	-

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years

Secondary Outcome Measures

Name	Time	Method
disease control rate	2 years
Progression-free survival	2 years
Radiological response	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

Trial Locations

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong