Treatment ResponsePhase 2PDTNCT02725073
Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma
A Phase 2 study testing Photodynamic therapy in people with Treatment Response and Adverse Events, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Treatment Response, Adverse Events, Feasibility
- What is being tested?
- Photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2016to Dec 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection
- Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center
- Pathologically proven cholangiocarcinoma
- have a negative pregnancy test if appropriate
- ECOG(Eastern Cooperative Oncology Group) Score 0-2
- patients to give informed consent and age more than >19 years
Who cannot join
- age less than 18 years
- previous history of PDT
- uncorrectable coagulopathy
- refuse to participate
- pregnancy
- recent participation in another clinical research trial within 30 days
- presence of porphyria or hypersensitivity to photosensitizer
- Creatinine clearance < 45ml
Trial locations and contacts
2 sites in 1 country.
Jun Ho Choi, MD contact
South Korea2 sites, 2 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Do Hyun Park, MD, PhD, 82230103194, dhpark@amc.seoul.kr
Jun Ho Choi, MD, mdcjh78@gmail.com
- Recruiting
Do Hyun Park
Seoul
Do Hyun Park, MD, PhD, +82-2-3010-3194, dhpark@amc.seoul.kr
Jun Ho Choi, MD, +82-2-3010-3194, mdcjh78@gmail.com
About this study
Official title: Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma
To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.
Read the detailed description
Photodynamic therapy (PDT) is a way of producing tissue necrosis with light after prior administration of a photosensitizing agent. The most important advantages include the possibility of combining PDT with other target therapies and repeat the process as needed with a favorable outcomes. The combination of diverse therapeutic modalities is one of the new strategies to enhance oncologic treatments for pancreatic cancer. In order to overcome the limitations of each treatment modalities and to prevent the development of resistance, the application of PDT combined with target therapies, without increasing the toxicity for the patient, is being widely investigated.
PDT has been only extensively studied for the treatment of various superficial skin cancers in the Europe but not available in the United States and Japan due to the overlapping treatment fields. In Korea, the use of first-generation and second-generation photosensitizers are part of the study of Gastroenterology, Dermatology, Otolaryngology, and Gynecology.
Recently, although the investigators have introduced PDT using novel photosensitizers has not yet been used for the treatment of pancreatic cancers. This study aim to determine the safety and efficacy of photodynamic therapy with a novel photosensitizer in locally advanced hilar cholangiocarcinoma.
- Conditions
- Treatment Response, Adverse Events, Feasibility
- Being tested
- Photodynamic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyProcedure or surgery
Photolon (Belmedpreparaty, Minsk, Republic of Belarus), was administered intravenously at a dose of 2.5 mg/kg at 3 hours before illumination. After advancing a catheter (7 F inner sheath of a plastic stent delivery catheter [MAJ-1419; Olympus America, Center Valley, Pa., USA]) across the biliary stricture using a 0.035-in guidewire, the cylindrical diffuser is inserted into a catheter at the level of the stricture to be treated. Photoactivation (660 nm with a light dose of 100-150J/cm2, and fluence of 0.8-1W/cm2; UPL- FDT; LEMT Research \& Development Private Unitary Enterprise, Minsk, Republic of Belarus) is performed
| Study group | Role | What they receive |
|---|---|---|
| photodynamic therapy | Experimental | Photodynamic therapy with a novel photosensitizer and flexible laser catheter Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Measured: within 1 month
Secondary outcomes (1)
Adverse events and overall survival
any procedural adverse events and overall survival
Measured: within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment ResponseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Hyun Park, Asan Medical Center
- Investigators
- Do Hyun Park, Md, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725073
- Sponsor's protocol ID
- ERCP-PDT
- Acronym
- PDT
- Status last verified
- Apr 2016
- First submitted
- 20 Mar 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT02725073
- Acronym / sponsor ID
- PDT / ERCP-PDT
- Conditions
- Treatment Response, Adverse Events, Feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Mar 2016 (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.
To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.
Detailed description
Photodynamic therapy (PDT) is a way of producing tissue necrosis with light after prior administration of a photosensitizing agent. The most important advantages include the possibility of combining PDT with other target therapies and repeat the process as needed with a favorable outcomes. The combination of diverse therapeutic modalities is one of the new strategies to enhance oncologic treatments for pancreatic cancer. In order to overcome the limitations of each treatment modalities and to prevent the development of resistance, the application of PDT combined with target therapies, without increasing the toxicity for the patient, is being widely investigated.
PDT has been only extensively studied for the treatment of various superficial skin cancers in the Europe but not available in the United States and Japan due to the overlapping treatment fields. In Korea, the use of first-generation and second-generation photosensitizers are part of the study of Gastroenterology, Dermatology, Otolaryngology, and Gynecology.
Recently, although the investigators have introduced PDT using novel photosensitizers has not yet been used for the treatment of pancreatic cancers. This study aim to determine the safety and efficacy of photodynamic therapy with a novel photosensitizer in locally advanced hilar cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| photodynamic therapy | Experimental | Procedure: Photodynamic therapyPhotodynamic therapy with a novel photosensitizer and flexible laser catheter |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection
- Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center
- Pathologically proven cholangiocarcinoma
- have a negative pregnancy test if appropriate
- ECOG(Eastern Cooperative Oncology Group) Score 0-2
Key exclusion criteria (8 listed)
- age less than 18 years
- previous history of PDT
- uncorrectable coagulopathy
- refuse to participate
- pregnancy
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 |
|---|---|---|
| Photodynamic therapyPhotolon (Belmedpreparaty, Minsk, Republic of Belarus), was administered intravenously at a dose of 2.5 mg/kg at 3 hours before illumination. After advancing a catheter (7 F inner sheath of a plastic stent delivery catheter [MAJ-1419; Olympus America, Center Valley, Pa., USA]) across the biliary stricture using a 0.035-in guidewire, the cylindrical diffuser is inserted into a catheter at the level of the stricture to be treated. Photoactivation (660 nm with a light dose of 100-150J/cm2, and fluence of 0.8-1W/cm2; UPL- FDT; LEMT Research \& Development Private Unitary Enterprise, Minsk, Republic of Belarus) is performed | Procedure or surgery | photodynamic therapy |
Primary outcome
Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Time frame: within 1 month
Response Evaluation Criteria in Solid Tumours (RECIST) criteria
1 secondary outcome
Adverse events and overall survival
Time frame: within 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Individual participant dataSharing planned: Yes
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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.
Jun Ho Choi, MD contact
Do Hyun Park, Md, PhD principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photodynamic therapy in people with Treatment Response and Adverse Events, run by Asan Medical Center at 2 sites in South Korea.
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 6 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 14 Apr 2016. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Do Hyun Park, MD, PhD (+82-2-3010-32194, dhpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria (time frame: within 1 month). 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 14 Apr 2016.