Trial record 1 of 188582 for:    ALL
Previous Study | Return to List | Next Study

Treatment for Bile Duct Cancer in the Liver

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02167711
First received: June 17, 2014
Last updated: March 3, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Cholangio Carcinoma
Drug: SIRT Yttrium-90
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Radiological response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • disease control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Duration between timing of chemotherapy and SIRT-Y90 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rate and severity of toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Serological response in CA 19.9 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIRT Drug: SIRT Yttrium-90

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02167711

Contacts
Contact: Stephen L Chan, FRCP 2632 2118 l_chan@clo.cuhk.edu.hk
Contact: Jane Koh, RN 2632 1142 jane@clo.cuhk.edu.hk

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Stephen L Chan, FRCP    2632 2118    l_chan@clo.cuhk.edu.hk   
Contact: Jane Koh, RN    2632 1142    jane@clo.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Stephen L Chan, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02167711     History of Changes
Other Study ID Numbers: BTC001
Study First Received: June 17, 2014
Last Updated: March 3, 2015
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on April 19, 2015