Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma (Photodynamic T)
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Wenlong Zhai, MD
- Número de telefone: +86-371-66913095
- E-mail: fcczhaiwl@zzu.edu.cn
Locais de estudo
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Henan
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Zhengzhou, Henan, China, 450052
- Recrutamento
- The First Affiliated Hospital of Zhengzhou University
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Contato:
- Wenlong Zhai, MD
- Número de telefone: +86-371-66913095
- E-mail: fcczhaiwl@zzu.edu.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Experimental: PDT combined with Radioactive Stent
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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Tumor response and biliary patency evaluated by RECIST v1.1
Prazo: From baseline up to 24 months
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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). |
From baseline up to 24 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: From enrollment up to 24 months
|
Time from enrollment to death from any cause. |
From enrollment up to 24 months
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|
Duration of stent patency
Prazo: From stent implantation up to 24 months
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Time from stent implantation to stent occlusion or dysfunction. |
From stent implantation up to 24 months
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|
Incidence of adverse events and complications
Prazo: From baseline up to 24 months
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Incidence and severity of adverse events (e.g., biliary perforation, infection, cholangitis, photosensitivity) evaluated according to CTCAE v5.0. |
From baseline up to 24 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zhai, MD, The First Affiliated Hospital of Zhengzhou University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Carcinoma
- Colangiocarcinoma
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, anel fundido
- Terapêutica
- Terapia medicamentosa
- Azoles
- Pigmentos, biológicos
- Fatores biológicos
- Compostos policíclicos
- Compostos heterocíclicos, 4 ou mais anéis
- Pirróis
- Compostos macrocíclicos
- Terapia de modalidade combinada
- Fototerapia
- Porfirinas
- Tetrapirroles
- Hematoporfirinas
- Fotochemoterapia
Outros números de identificação do estudo
- ZZU-2025-PDT-001
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