Cholangio CarcinomaPhase 2NCT02167711
Treatment for Bile Duct Cancer in the Liver
A Phase 2 study testing SIRT Yttrium-90 in people with Cholangio Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangio Carcinoma
- What is being tested?
- SIRT Yttrium-90
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Sep 2014to 8 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study
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
- Being tested
- SIRT Yttrium-90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRT Yttrium-90Drug
| Study group | Role | What they receive |
|---|---|---|
| SIRT | Experimental | Not described Receives: Drug: SIRT Yttrium-90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (6)
Progression-free survival
Measured: 2 years
Radiological response
Measured: 2 years
disease control rate
Measured: 2 years
Duration between timing of chemotherapy and SIRT-Y90
Measured: 2 years
Rate and severity of toxicities
Measured: 2 years
Serological response in CA 19.9
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study start17 Sep 2014
- Primary completion31 Jan 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangio CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Stephen L Chan, FRCP, Principal investigator, Department of Clinical Oncology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167711
- Sponsor's protocol ID
- BTC001
- Status last verified
- Apr 2023
- First submitted
- 17 Jun 2014
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study
- ClinicalTrials.gov ID
- NCT02167711
- Acronym / sponsor ID
- BTC001
- Conditions
- Cholangio Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 17 Sep 2014 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIRT | Experimental | Drug: SIRT Yttrium-90 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIRT Yttrium-90 | Drug | SIRT |
Primary outcome
Overall survival
Time frame: 2 years
6 secondary outcomes
Progression-free survival
Time frame: 2 years
Radiological response
Time frame: 2 years
disease control rate
Time frame: 2 years
Duration between timing of chemotherapy and SIRT-Y90
Time frame: 2 years
Rate and severity of toxicities
Time frame: 2 years
Serological response in CA 19.9
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L Chan, FRCP principal investigator
Department of Clinical Oncology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SIRT Yttrium-90 in people with Cholangio Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.