Treatment for Bile Duct Cancer in the Liver

Cholangio Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167711
• Other study ID #: BTC001
• Status: Completed
• Phase: Phase 2
• Start date: September 17, 2014
• Est. completion date: February 8, 2023

Study information

• Verified date: April 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 8, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangio Carcinoma
• Cholangiocarcinoma

Intervention

Drug:
• SIRT Yttrium-90

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2 years
Secondary	Progression-free survival		2 years
Secondary	Radiological response		2 years
Secondary	disease control rate		2 years
Secondary	Duration between timing of chemotherapy and SIRT-Y90		2 years
Secondary	Rate and severity of toxicities		2 years
Secondary	Serological response in CA 19.9		2 years