Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Hematoporphyrin Injection: Intravenous injection of photosensitizer at a dose of 3mg/kg before PDT.

Self-expandable radioactive particle-loaded biliary stent: Implantation of a biliary stent loaded with Iodine-125 radioactive particles for biliary drainage and local brachytherapy.

Photodynamic Therapy (PDT): DSA-guided biliary tumor biopsy and photodynamic laser irradiation (1-2 sessions).

Percutaneous transhepatic cholangial drainage (PTCD): Initial biliary drainage to improve liver function and reduce infection risk before PDT.

Study 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.

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.

Eligibility

Primary outcome measure(s)

• Tumor response and biliary patency evaluated by RECIST v1.1 — 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).

Trial sites (1)

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