search
Back to results

Treatment for Bile Duct Cancer in the Liver

Primary Purpose

Cholangio Carcinoma

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
SIRT Yttrium-90
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangio Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Oncology, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIRT

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival
Radiological response
disease control rate
Duration between timing of chemotherapy and SIRT-Y90
Rate and severity of toxicities
Serological response in CA 19.9

Full Information

First Posted
June 17, 2014
Last Updated
April 20, 2023
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT02167711
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2014 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
February 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangio Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIRT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SIRT Yttrium-90
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2 years
Title
Radiological response
Time Frame
2 years
Title
disease control rate
Time Frame
2 years
Title
Duration between timing of chemotherapy and SIRT-Y90
Time Frame
2 years
Title
Rate and severity of toxicities
Time Frame
2 years
Title
Serological response in CA 19.9
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen L Chan, FRCP
Organizational Affiliation
Department of Clinical Oncology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Treatment for Bile Duct Cancer in the Liver

We'll reach out to this number within 24 hrs