Intrahepatic CholangiocarcinomaNCT02238613
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
A study testing radioactive stent and plastic stent in people with Intrahepatic Cholangiocarcinoma and Cholangiocarcinoma of the Extrahepatic Bile Duct, run by 307 Hospital of PLA at 1 site in China.
Trial summary
The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampullary Carcinoma
- What is being tested?
- radioactive stent and plastic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jun 2017
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
- Patients aged between 18 and 80 years
- an estimated life expectancy of more than 3 months
- Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
- TNM stage III-IV
- no evidence of cancer of another organ.
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- no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed
- Karnofsky index of ≥60%
- ECOG index ≥2
- previous technically successful stenting or ENBD derange
- Accept of informed consent
Who cannot join
- Clinically significant cardiovascular disease
- coagulation disorders
- contraindication of Endoscopic
- pregnant or breastfeeding women
- known sensitivity sensitivity to investigated agents or components
- recent invasive procedure
- prior chemotherapy or radiotherapy for biliary cancer
- refusal of informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
307 hospital of PLA
Beijing, Beijing Municipality, 10086
Zhaoshen Li, Doctor
Min Min, M.D. PhD.
About this study
Official title: Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.
Read the detailed description
Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.
- Conditions
- Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampullary Carcinoma, Biliary Obstruction
- Being tested
- radioactive stent, plastic stent
- Keywords
- Radioactive stents, Brachytherapy, Biliary obstruction, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, ampullary carcinoma
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioactive stentDevice
Also called brand names: carriable radioactive bile duct plastic stent, serial numbers and code name: PBS1-A/B-10/160/140
radioactive stent carrying seed iodine 125
plastic stentDevice
common plastic stent without carrying seed iodine 125
| Study group | Role | What they receive |
|---|---|---|
| radioactive stent | Experimental | The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients. Receives: Device: radioactive stent |
| plastic stent | Other | The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients. Receives: Device: plastic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response rate
The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
Measured: 3 months
Secondary outcomes (3)
Progression-free survival
In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.
Measured: 6 months
overall survival
Overall survival was calculated from the date of randomization until the date of death.
Measured: follow-up in interval of stent insertion and death (1 years)
Adverse events
Individual adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 307 Hospital of PLA
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changhai Hospital
- Responsible party
- Principal investigator, yan liu, 307 Hospital of PLA
- Investigators
- Yan Liu, Doctor, Principal investigator, 307 hospital of PLA, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238613
- Sponsor's protocol ID
- yanliu307
- Other IDs
- 307xhk
- Status last verified
- Sep 2014
- First submitted
- 25 Aug 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT02238613
- Acronym / sponsor ID
- yanliu307
- Conditions
- Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampullary Carcinoma, Biliary Obstruction
- Keywords
- Radioactive stents, Brachytherapy, Biliary obstruction, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, ampullary carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- 307 Hospital of PLAUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changhai Hospital
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 12 Sep 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 purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.
Detailed description
Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radioactive stent | Experimental | Device: radioactive stentThe radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients. |
| plastic stent | Other | Device: plastic stentThe plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
- Patients aged between 18 and 80 years
- an estimated life expectancy of more than 3 months
- Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
- TNM stage III-IV
Key exclusion criteria (8 listed)
- Clinically significant cardiovascular disease
- coagulation disorders
- contraindication of Endoscopic
- pregnant or breastfeeding women
- known sensitivity sensitivity to investigated agents or components
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 |
|---|---|---|
| radioactive stentAlso: brand names: carriable radioactive bile duct plastic stent, serial numbers and code name: PBS1-A/B-10/160/140radioactive stent carrying seed iodine 125 | Device | radioactive stent |
| plastic stentcommon plastic stent without carrying seed iodine 125 | Device | plastic stent |
Primary outcome
Tumor Response rate
Time frame: 3 months
The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
3 secondary outcomes
Progression-free survival
Time frame: 6 months
overall survival
Time frame: follow-up in interval of stent insertion and death (1 years)
Adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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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.
Yan Liu, Doctor principal investigator
307 hospital of PLA, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radioactive stent and plastic stent in people with Intrahepatic Cholangiocarcinoma and Cholangiocarcinoma of the Extrahepatic Bile Duct, run by 307 Hospital of PLA at 1 site in China.
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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Sep 2014. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Liu, MD,PhD (86-13911798288, 13911798288@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response rate (time frame: 3 months). 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 12 Sep 2014.