PDT plus radioactive biliary stent for unresectable extrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm interventional study enrolling adults with unresectable extrahepatic cholangiocarcinoma. After initial biliary drainage, a photosensitizer is given and, 48–72 hours later, PDT is performed under imaging guidance. Subsequently, a self-expandable biliary stent loaded with Iodine-125 is implanted to provide ongoing local brachytherapy and maintain biliary patency. The primary outcome is tumor response or biliary patency by RECIST v1.1, with safety and follow-up as secondary considerations. The approach aims to synergize tumor destruction from PDT with continuous local irradiation to slow progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Zhai, MD — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Wenlong Zhai, MD
• Email: fcczhaiwl@zzu.edu.cn
• Phone: +86-371-66913095

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.