Extrahepatic CholangiocarcinomaPhotodynamic TNCT07916870
Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
A study testing Hematoporphyrin Injection, Self-expandable radioactive particle-loaded biliary stent and Photodynamic Therapy (PDT) in people with Extrahepatic Cholangiocarcinoma, run by Zhai Wenlong at 1 site in China.
Trial summary
This is a prospective, single-arm, interventional clinical study. The purpose of this study is to evaluate the clinical efficacy and safety of Photodynamic Therapy (PDT) combined with a self-expandable radioactive particle-loaded biliary stent in patients with unresectable extrahepatic cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrahepatic Cholangiocarcinoma
- What is being tested?
- Hematoporphyrin Injection, Self-expandable radioactive particle-loaded biliary stent and Photodynamic Therapy (PDT)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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, male or female.
- Histologically, cytologically, or radiologically confirmed extrahepatic cholangiocarcinoma.
- Poor cardiopulmonary or renal function, unable to tolerate surgical resection.
- Extensive tumor invasion, unable to achieve complete surgical resection.
- Unable to tolerate surgery due to age or other factors.
- Patients who refuse surgical treatment.
- Participants voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- Allergic to photosensitizers.
- Severe liver dysfunction, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
- Severe coagulation disorders that cannot be corrected.
- Active biliary tract infection.
- Severe renal insufficiency.
- Cachexia with an expected survival of less than 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wenlong Zhai, MD, +86-371-66913095, fcczhaiwl@zzu.edu.cn
About this study
Official title: A Clinical Study on the Application Value of Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent in Unresectable Extrahepatic Cholangiocarcinoma
This is a prospective, single-arm, interventional clinical study. The purpose of this study is to evaluate the clinical efficacy and safety of Photodynamic Therapy (PDT) combined with a self-expandable radioactive particle-loaded biliary stent in patients with unresectable extrahepatic cholangiocarcinoma.
Patients diagnosed with extrahepatic cholangiocarcinoma who are unable to undergo surgical resection will be enrolled. After initial percutaneous transhepatic cholangial drainage (PTCD) to improve liver function, patients will receive an intravenous injection of a photosensitizer (Hematoporphyrin, 3 mg/kg). Approximately 48-72 hours later, PDT will be performed under DSA guidance (1-2 sessions). Subsequently, a self-expandable biliary stent loaded with Iodine-125 radioactive particles will be implanted into the stricture to maintain biliary patency and provide local brachytherapy.
The primary outcome is tumor response or biliary patency evaluated by RECIST v1.1. Secondary outcomes include overall survival, stent patency duration, changes in liver function and tumor markers, and incidence of adverse events. This study aims to provide a new, effective treatment strategy for unresectable extrahepatic cholangiocarcinoma.
Read the detailed description
Background: Extrahepatic cholangiocarcinoma is often diagnosed at an advanced stage, precluding curative surgery. Traditional treatments like chemotherapy and radiotherapy have limited efficacy. Photodynamic therapy (PDT) is a minimally invasive local treatment that can destroy tumor cells, but its effective depth is limited (4-6 mm), which may lead to rapid tumor progression or recurrent biliary obstruction. The self-expandable radioactive particle-loaded biliary stent not only provides mechanical biliary drainage but also delivers continuous local brachytherapy (Iodine-125) to inhibit tumor growth. This study proposes that combining PDT with this radioactive stent may provide synergistic effects, prolonging stent patency and improving survival for patients with unresectable extrahepatic cholangiocarcinoma.
Study Design: Prospective, single-arm, interventional clinical study.
Procedures:
PTCD will be performed first to relieve jaundice and improve liver function.
A skin test for photosensitizer allergy will be conducted. If negative, Hematoporphyrin (3mg/kg) will be administered intravenously.
48-72 hours later, DSA-guided biliary tumor biopsy and PDT will be performed (1-2 sessions depending on tolerance).
A self-expandable biliary stent loaded with Iodine-125 particles will be implanted into the stricture after balloon dilation. The drainage tube will be kept for 1-2 weeks post-operation and then removed.
Follow-up: Patients will be followed up every 3-4 weeks initially, and then every 3 months after stabilization (up to 2 years) to monitor tumor response, survival, stent patency, liver function, and adverse events.
- Conditions
- Extrahepatic Cholangiocarcinoma
- Being tested
- Hematoporphyrin Injection, Self-expandable radioactive particle-loaded biliary stent, Photodynamic Therapy (PDT), Percutaneous transhepatic cholangial drainage (PTCD)
- Keywords
- Photodynamic Therapy, Biliary Stent, Iodine-125, Brachytherapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematoporphyrin InjectionDrug
Intravenous injection of photosensitizer at a dose of 3mg/kg before PDT.
Self-expandable radioactive particle-loaded biliary stentDevice
Implantation of a biliary stent loaded with Iodine-125 radioactive particles for biliary drainage and local brachytherapy.
Photodynamic Therapy (PDT)Procedure or surgery
DSA-guided biliary tumor biopsy and photodynamic laser irradiation (1-2 sessions).
Percutaneous transhepatic cholangial drainage (PTCD)Procedure or surgery
Initial biliary drainage to improve liver function and reduce infection risk before PDT.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: PDT combined with Radioactive Stent | Experimental | Patients will first undergo percutaneous transhepatic cholangial drainage (PTCD). After a negative skin test, Hematoporphyrin (3mg/kg) will be injected intravenously. 48-72 hours later, Photodynamic Therapy (PDT) will be performed under DSA guidance. Subsequently, a self-expandable biliary stent loaded with Iodine-125 radioactive particles will be implanted. Receives: Drug: Hematoporphyrin Injection; Device: Self-expandable radioactive particle-loaded biliary stent; Procedure: Photodynamic Therapy (PDT); Procedure: Percutaneous transhepatic cholangial drainage (PTCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response and biliary patency evaluated by RECIST v1.1
Tumor response will be assessed by RECIST v1.1 using upper abdominal contrast-enhanced MRI or CT. Biliary patency will be evaluated based on imaging and liver function tests (e.g., total, direct, and indirect bilirubin).
Measured: From baseline up to 24 months
Secondary outcomes (3)
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: From enrollment up to 24 months
Duration of stent patency
Time from stent implantation to stent occlusion or dysfunction.
Measured: From stent implantation up to 24 months
Incidence of adverse events and complications
Incidence and severity of adverse events (e.g., biliary perforation, infection, cholangitis, photosensitivity) evaluated according to CTCAE v5.0.
Measured: From baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 May 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhai Wenlong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhai Wenlong, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Zhai, MD, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916870
- Sponsor's protocol ID
- ZZU-2025-PDT-001
- Acronym
- Photodynamic T
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Application Value of Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent in Unresectable Extrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT07916870
- Acronym / sponsor ID
- Photodynamic T / ZZU-2025-PDT-001
- Conditions
- Extrahepatic Cholangiocarcinoma
- Keywords
- Photodynamic Therapy, Biliary Stent, Iodine-125, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhai WenlongUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- 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.
This is a prospective, single-arm, interventional clinical study. The purpose of this study is to evaluate the clinical efficacy and safety of Photodynamic Therapy (PDT) combined with a self-expandable radioactive particle-loaded biliary stent in patients with unresectable extrahepatic cholangiocarcinoma.
Patients diagnosed with extrahepatic cholangiocarcinoma who are unable to undergo surgical resection will be enrolled. After initial percutaneous transhepatic cholangial drainage (PTCD) to improve liver function, patients will receive an intravenous injection of a photosensitizer (Hematoporphyrin, 3 mg/kg). Approximately 48-72 hours later, PDT will be performed under DSA guidance (1-2 sessions). Subsequently, a self-expandable biliary stent loaded with Iodine-125 radioactive particles will be implanted into the stricture to maintain biliary patency and provide local brachytherapy.
The primary outcome is tumor response or biliary patency evaluated by RECIST v1.1. Secondary outcomes include overall survival, stent patency duration, changes in liver function and tumor markers, and incidence of adverse events. This study aims to provide a new, effective treatment strategy for unresectable extrahepatic cholangiocarcinoma.
Detailed description
Background: Extrahepatic cholangiocarcinoma is often diagnosed at an advanced stage, precluding curative surgery. Traditional treatments like chemotherapy and radiotherapy have limited efficacy. Photodynamic therapy (PDT) is a minimally invasive local treatment that can destroy tumor cells, but its effective depth is limited (4-6 mm), which may lead to rapid tumor progression or recurrent biliary obstruction. The self-expandable radioactive particle-loaded biliary stent not only provides mechanical biliary drainage but also delivers continuous local brachytherapy (Iodine-125) to inhibit tumor growth. This study proposes that combining PDT with this radioactive stent may provide synergistic effects, prolonging stent patency and improving survival for patients with unresectable extrahepatic cholangiocarcinoma.
Study Design: Prospective, single-arm, interventional clinical study.
Procedures:
PTCD will be performed first to relieve jaundice and improve liver function.
A skin test for photosensitizer allergy will be conducted. If negative, Hematoporphyrin (3mg/kg) will be administered intravenously.
48-72 hours later, DSA-guided biliary tumor biopsy and PDT will be performed (1-2 sessions depending on tolerance).
A self-expandable biliary stent loaded with Iodine-125 particles will be implanted into the stricture after balloon dilation. The drainage tube will be kept for 1-2 weeks post-operation and then removed.
Follow-up: Patients will be followed up every 3-4 weeks initially, and then every 3 months after stabilization (up to 2 years) to monitor tumor response, survival, stent patency, liver function, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: PDT combined with Radioactive Stent | Experimental | Drug: Hematoporphyrin Injection, Device: Self-expandable radioactive particle-loaded biliary stent, Procedure: Photodynamic Therapy (PDT), Procedure: Percutaneous transhepatic cholangial drainage (PTCD)Patients will first undergo percutaneous transhepatic cholangial drainage (PTCD). After a negative skin test, Hematoporphyrin (3mg/kg) will be injected intravenously. 48-72 hours later, Photodynamic Therapy (PDT) will be performed under DSA guidance. Subsequently, a self-expandable biliary stent loaded with Iodine-125 radioactive particles will be implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years, male or female.
- Histologically, cytologically, or radiologically confirmed extrahepatic cholangiocarcinoma.
- Poor cardiopulmonary or renal function, unable to tolerate surgical resection.
- Extensive tumor invasion, unable to achieve complete surgical resection.
- Unable to tolerate surgery due to age or other factors.
Key exclusion criteria (6 listed)
- Allergic to photosensitizers.
- Severe liver dysfunction, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
- Severe coagulation disorders that cannot be corrected.
- Active biliary tract infection.
- Severe renal insufficiency.
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 |
|---|---|---|
| Hematoporphyrin InjectionIntravenous injection of photosensitizer at a dose of 3mg/kg before PDT. | Drug | Experimental: PDT combined with Radioactive Stent |
| Self-expandable radioactive particle-loaded biliary stentImplantation of a biliary stent loaded with Iodine-125 radioactive particles for biliary drainage and local brachytherapy. | Device | Experimental: PDT combined with Radioactive Stent |
| Photodynamic Therapy (PDT)DSA-guided biliary tumor biopsy and photodynamic laser irradiation (1-2 sessions). | Procedure or surgery | Experimental: PDT combined with Radioactive Stent |
| Percutaneous transhepatic cholangial drainage (PTCD)Initial biliary drainage to improve liver function and reduce infection risk before PDT. | Procedure or surgery | Experimental: PDT combined with Radioactive Stent |
Primary outcome
Tumor response and biliary patency evaluated by RECIST v1.1
Time frame: From baseline up to 24 months
Tumor response will be assessed by RECIST v1.1 using upper abdominal contrast-enhanced MRI or CT. Biliary patency will be evaluated based on imaging and liver function tests (e.g., total, direct, and indirect bilirubin).
3 secondary outcomes
Overall Survival (OS)
Time frame: From enrollment up to 24 months
Duration of stent patency
Time frame: From stent implantation up to 24 months
Incidence of adverse events and complications
Time frame: From baseline up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Zhai, MD principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hematoporphyrin Injection, Self-expandable radioactive particle-loaded biliary stent and Photodynamic Therapy (PDT) in people with Extrahepatic Cholangiocarcinoma, run by Zhai Wenlong 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 7 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenlong Zhai, MD (+86-371-66913095, fcczhaiwl@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response and biliary patency evaluated by RECIST v1.1 (time frame: From baseline up to 24 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 4 Nov 2026.