Treatment for Bile Duct Cancer in the Liver

NCT02167711 | Completed Phase 2

• 1 other identifier: BTC001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangio Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 years

Secondary Outcomes (6)

• 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

Study Arms (1)

SIRT

EXPERIMENTAL

Drug: SIRT Yttrium-90

Interventions

SIRT Yttrium-90 DRUG

SIRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Study Officials

• Stephen L Chan, FRCP

  Department of Clinical Oncology, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comprehensive Clinical Trial Unit

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: September 17, 2014
• Primary Completion: January 31, 2023
• Study Completion: February 8, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

HK (1)