NCT02167711

CompletedPhase 2

Treatment for Bile Duct Cancer in the Liver

Chinese University of Hong Kong Source

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Other study identifiers

Sponsor study identifier

BTC001

Study Type

interventional

Actual enrollment (reported)

24

Locations

1 country

Sites

1

Timeline

Study Start

September 17, 2014

Actual (reported)

Primary Completion

January 31, 2023

Actual (reported)

Study Completion

February 8, 2023

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: February 8, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 17, 2014
Actual (reported)
First Posted
June 19, 2014
Actual (reported)
Study Start
September 17, 2014
Actual (reported)
Primary Completion
January 31, 2023
Actual (reported)
Study Completion
February 8, 2023
Actual (reported)

Last Updated: April 21, 2023
Status Verified: April 2023
Last Update Submitted: April 20, 2023

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
+1 more secondary outcomes

Study Arms (1)

SIRT

EXPERIMENTAL

Drug: SIRT Yttrium-90

Interventions

SIRT Yttrium-90Drug

SIRT

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age\>18 years
Histological or cytological diagnosis of cholangiocarcinoma

Sponsors & Collaborators

Chinese University of Hong Kong
Otherlead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Study Officials

Stephen L Chan, FRCP
Department of Clinical Oncology, The Chinese University of Hong Kong
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

+1 more criteria

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

Contact the study team to confirm eligibility.

Primary Completion

January 31, 2023

Actual (reported)

Study Completion

February 8, 2023

Actual (reported)

Last Updated

April 21, 2023

Record last verified: 2023-04

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02167711
Data provider: ClinicalTrials.gov
Source updated: 2023-04-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:22 UTC

Locations

HK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

SIRT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations