CholangiocarcinomaPhase 2/3NCT01739465
Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma
A Phase 2/3 study testing Self expanding metallic stent (SEMS), Endoscopic radiofrequency ablation (ERFA) and Photodynamic therapy (PDT) in people with Cholangiocarcinoma, run by Guangzhou Medical University at 2 sites in China.
Trial summary
The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Self expanding metallic stent (SEMS), Endoscopic radiofrequency ablation (ERFA) and Photodynamic therapy (PDT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2012to Dec 2015
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Pathologically or radiologically confirmed biliary malignant
- Inoperability by staging
Who cannot join
- Cholangiocarcinoma with widespread metastasis
- Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
- Prior SEMS placement
- Pregnancy
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
- Life expectancy < 3months
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
The Second Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510260
Huihong Liang, MD, +86-188-2648-8232, beanth@163.com
- Recruiting
The second hospital of Guangzhou Medical college
Guangzhou, Guangdong, 510260
Huihong Liang, Doctorial, +86-188-2648-8232, beanth@163.com
Huihong Liang, Doctoral
About this study
Official title: A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma
- Conditions
- Cholangiocarcinoma
- Being tested
- Self expanding metallic stent (SEMS), Endoscopic radiofrequency ablation (ERFA), Photodynamic therapy (PDT)
- Keywords
- Cholangiocarcinoma, Pathologic, Digestive System, Neoplasms, Neoplasms by Site, Digestive System Diseases, Bile Duct Diseases, Biliary Tract Diseases, Pathological Conditions, Constriction, Adenocarcinoma, Carcinoma
- Medical subject headings
- Cholangiocarcinoma, Neoplasms, Neoplasms by Site, Digestive System Diseases, Bile Duct Diseases, Biliary Tract Diseases, Constriction, Pathologic, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self expanding metallic stent (SEMS)Procedure or surgery
Self expanding metallic stent
Endoscopic radiofrequency ablation (ERFA)Procedure or surgery
Endoscopic radiofrequency ablation
Photodynamic therapy (PDT)Procedure or surgery
Photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Self expanding metallic stent （SEMS ）placement only | Active comparator | Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing Receives: Procedure: Self expanding metallic stent (SEMS) |
| Endoscopic radiofrequency ablation plus SEMS | Experimental | Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing Receives: Procedure: Self expanding metallic stent (SEMS); Procedure: Endoscopic radiofrequency ablation (ERFA) |
| Photodynamic therapy plus SEMS | Experimental | Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing Receives: Procedure: Self expanding metallic stent (SEMS); Procedure: Photodynamic therapy (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent patency
Measured: 6 months
Secondary outcomes (1)
overall survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huihong Liang, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739465
- Sponsor's protocol ID
- RFA2012
- Status last verified
- Feb 2013
- First submitted
- 29 Nov 2012
- Last updated
- 26 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT01739465
- Acronym / sponsor ID
- RFA2012
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, Pathologic, Digestive System, Neoplasms, Neoplasms by Site, Digestive System Diseases, Bile Duct Diseases, Biliary Tract Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (estimated)
- First posted
- 3 Dec 2012 (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 compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self expanding metallic stent （SEMS ）placement only | Active comparator | Procedure: Self expanding metallic stent (SEMS)Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing |
| Endoscopic radiofrequency ablation plus SEMS | Experimental | Procedure: Self expanding metallic stent (SEMS), Procedure: Endoscopic radiofrequency ablation (ERFA)Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing |
| Photodynamic therapy plus SEMS | Experimental | Procedure: Self expanding metallic stent (SEMS), Procedure: Photodynamic therapy (PDT)Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Pathologically or radiologically confirmed biliary malignant
- Inoperability by staging
Key exclusion criteria (6 listed)
- Cholangiocarcinoma with widespread metastasis
- Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
- Prior SEMS placement
- Pregnancy
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
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 |
|---|---|---|
| Self expanding metallic stent (SEMS)Self expanding metallic stent | Procedure or surgery | Endoscopic radiofrequency ablation plus SEMS, Photodynamic therapy plus SEMS, Self expanding metallic stent （SEMS ）placement only |
| Endoscopic radiofrequency ablation (ERFA)Endoscopic radiofrequency ablation | Procedure or surgery | Endoscopic radiofrequency ablation plus SEMS |
| Photodynamic therapy (PDT)Photodynamic therapy | Procedure or surgery | Photodynamic therapy plus SEMS |
Primary outcome
stent patency
Time frame: 6 months
1 secondary outcome
overall survival rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Self expanding metallic stent (SEMS), Endoscopic radiofrequency ablation (ERFA) and Photodynamic therapy (PDT) in people with Cholangiocarcinoma, run by Guangzhou Medical University at 2 sites 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 3 inclusion and 6 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 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Huihong Liang, MD (+86-20-34153043, beanth@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stent patency (time frame: 6 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 26 Feb 2013.