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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Wenlong Zhai, MD
- 電話番号：+86-371-66913095
- メール：fcczhaiwl@zzu.edu.cn
研究場所
-
-
Henan
-
Zhengzhou、Henan、中国、450052
- 募集
- The First Affiliated Hospital of Zhengzhou University
-
コンタクト：
- Wenlong Zhai, MD
- 電話番号：+86-371-66913095
- メール：fcczhaiwl@zzu.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tumor response and biliary patency evaluated by RECIST v1.1
時間枠：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). |
From baseline up to 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：From enrollment up to 24 months
|
Time from enrollment to death from any cause. |
From enrollment up to 24 months
|
|
Duration of stent patency
時間枠：From stent implantation up to 24 months
|
Time from stent implantation to stent occlusion or dysfunction. |
From stent implantation up to 24 months
|
|
Incidence of adverse events and complications
時間枠：From baseline up to 24 months
|
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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Zhai, MD、The First Affiliated Hospital of Zhengzhou University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ZZU-2025-PDT-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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