An interventional study of Hematoporphyrin Injection and Self-expandable radioactive particle-loaded biliary stent in Extrahepatic Cholangiocarcinoma, sponsored by Zhai Wenlong. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Zhai Wenlong · Not applicable, Interventional, and Treatment
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.
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.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 623 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Zhai Wenlong is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 form, have good compliance, and cooperate with follow-up.
Exclusion Criteria:
Severe liver dysfunction, hepatic encephalopathy, 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Hematoporphyrin Injection · Device: Self-expandable radioactive particle-loaded biliary stent · Procedure: Photodynamic Therapy (PDT) · Procedure: Percutaneous transhepatic cholangial drainage (PTCD)
Intravenous injection of photosensitizer at a dose of 3mg/kg before PDT.
Implantation of a biliary stent loaded with Iodine-125 radioactive particles for biliary drainage and local brachytherapy.
DSA-guided biliary tumor biopsy and photodynamic laser irradiation (1-2 sessions).
Initial biliary drainage to improve liver function and reduce infection risk before PDT.
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).
Time frame: From baseline up to 24 months
Overall Survival (OS)
Time from enrollment to death from any cause.
Time frame: From enrollment up to 24 months
Duration of stent patency
Time from stent implantation to stent occlusion or dysfunction.
Time frame: 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.
Time frame: From baseline up to 24 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2027, 31 months after the start.
Of 66 non-industry interventional studies with no phase under Cholangiocarcinoma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 28. This study's planned 31 months is below that.
Counting every sponsor, half of 67 studies reached it within 43 months; a quarter within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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