Light Therapy Plus Radioactive Bile Duct Stent for Inoperable Bile Duct Cancer
Tests light therapy with a radioactive stent in adults with bile duct cancer.
Plain-language title generated from the registry record
Registry title: Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
Key facts
- Where
- Zhengzhou, ChinaSee the site
Where in China
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhai Wenlong
- Trial code
- NCT07916870
- Record updated
- 4 November 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.