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Treatment for Bile Duct Cancer in the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02167711
Recruitment Status : Recruiting
First Posted : June 19, 2014
Last Update Posted : February 26, 2019
Information provided by (Responsible Party):
CCTU, 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.

Condition or disease Intervention/treatment Phase
Cholangio Carcinoma Drug: SIRT Yttrium-90 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study
Actual Study Start Date : September 17, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: SIRT Drug: SIRT Yttrium-90

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
  2. Radiological response [ Time Frame: 2 years ]
  3. disease control rate [ Time Frame: 2 years ]
  4. Duration between timing of chemotherapy and SIRT-Y90 [ Time Frame: 2 years ]
  5. Rate and severity of toxicities [ Time Frame: 2 years ]
  6. Serological response in CA 19.9 [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02167711

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Contact: Stephen L Chan, FRCP 35052166
Contact: Jane Koh, RN 35051142

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Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Stephen L Chan, FRCP    35052166   
Contact: Jane Koh, RN    35051142   
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Stephen L Chan, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong

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Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong Identifier: NCT02167711     History of Changes
Other Study ID Numbers: BTC001
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type