NCT07916870Recruiting
Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
A Clinical Study on the Application Value of Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent in Unresectable Extrahepatic Cholangiocarcinoma
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 30 May 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Zhai Wenlong
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07916870
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 30 May 2025 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.