Neoplasms

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Digestive System Diseases

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Cholangiocarcinoma

Klatskin Tumor

Bile Duct Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Antineoplastic Agents

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All Drugs and Chemicals

Temoporfin

Photosensitizing Agents

A single treatment with Temoporfin (Foscan) 3 mg given intravenously followed by PDT with laser light at 652 nm (Ceralas, Biolitec, Germany) within 72 hours

James YW LAU, MD

In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents in patients with inoperable bile duct cancers. In addition as a preliminary study we sought to determine if the treatment can reduce tumor volume in the short term.

Cholangiocarcinoma is a tumor associated with a grave prognosis. The only curative treatment is surgery or liver transplantation. Only about 10-20% of patients with the tumor are operated upon. In the majority of patients, the tumor is often diagnosed at a late stage. Many patients are not operated upon owing to their advanced age or comorbid illnesses. These patients suffer from intense pruritus a result of obstructive jaundice, recurrent biliary sepsis and progressive hepatic failure leading to death. Quality in life in these patients is poor. The median survival in these patients is around 6 months. The palliative treatment is stents inserted either at ERCP or through a percutaneous transhepatic route. Many return with recurrent cholangitis necessitating frequent stent changes. Photodynamic therapy (PDT) in combination with stenting is the only proven treatment that confers a survival benefit when compared to stenting alone. Two randomized controlled trials have shown significant survival advantage in patients treated by PDT in addition to stenting compared to stenting alone. Ortner et al. 1 randomized 39 patients with inoperable cholangiocarinoma to endoscopic stents with or without PDT. Median survival in those given PDT was 493 days compared to that of 98 days in those with stents alone. Survival difference was again wide in favor of PDT use in another randomized controlled study by Zoepf et al 2 (median survival 630 vs. 210 days). In addition, PDT improves quality of life and cholestasis in patients with cholangiocarcinoma. In a series from Germany, survival after PDT and stenting compared favorably to R1 and R2 resections. 3 Despite of the evidence, PDT for inoperable cholangiocarcinoma is not available in Hong Kong.

Meso-tetrahydroxyphenylchlorin (mTHPC, Foscan®) is a photosensitizer for PDT in cholangiocarcinoma. In compared with other agents such as Photofin and Photosan, PDT treatment using temoporfin at a low dose (3 mg per treatment) is associated with a deeper tissue penetration (4-6mm) and a reduced period of photosensitivity.

In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents in patients with inoperable bile duct cancers. In addition as a preliminary study we sought to determine if the treatment can reduce tumor volume in the short term.

Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers

Safety and Tumoricidal Effect of Low Dose Temoporfin Photodynamic Therapy in Patients With Inoperable Bile Duct Cancers (Foscan® Study)

Safety (will be graded according to the Common Terminology Criteria for Adverse Events

Tumor response as categorized by the World Health Organization criteria at 8

Relief of jaundice at 8 weeks (\<50% pretreatment serum bilirubin)

Cholangitis and stent occlusions requiring stent change (will be assessed based on blood tests and ERCP findings)

Quality of life (in every visit, European Organization for Research and Treatment of Cancer core questionnaire \[EORTC QLQ-C30\] will be filled and specific symptom enquiry is made; itchiness, fever and general well-being over a Likert 0-4 scale.

Chinese University of Hong Kong

Professor

WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2.5 and 5 mg/kg, using 753nm laser light at a fixed power (150 mW/cm) and light energy (200 J/cm). Illumination in the bile duct is performed by inserting a diffusing fiber, with cylindrical uniform light distribution, in a transparent standard ERCP catheter and by positioning, under radioscopy, the illumination tip of the diffusing fiber in front of the lesion.

WST11

Emmanuel Ben Soussan, MD

The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy with WST11 in patients with non-resectable or inoperable biliary carcinoma.

This is an open-label, prospective, multicentre, phase IIa study, evaluating a new therapeutic agent in the management of patients suffering from inoperable or non resectable biliary carcinoma. The patients will receive the dose of WST11 according to order of inclusion. The first 3 patients will receive 2.5 mg/kg. In the absence of toxicity, the following 9 patients will receive the dose of 5 mg/kg.

The patient is to receive anesthesia. WST11-mediated therapy will consist of the combination of single IV administration of WST11 at doses of 2.5mg/kg or 5mg/kg, using 753nm laser light at a fixed power of (150mW/cm) and light energy (200 J/cm) delivered through a diffusing fiber. The fiber is introduced in a transparent standard ERCP catheter and positioned under radioscopy in front of the lesion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers	NCT03003065	Cholangiocarcin... Tumor Klatskin Tumor	Temoporfin	18 Years -	Chinese University of Hong Kong
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma	NCT00975039	Cholangiocarcin...	WST11	18 Years -	Steba Biotech S.A.
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma	NCT00975039	Cholangiocarcin...	WST11	18 Years -	Steba Biotech S.A.

Spots Global Cancer Trial Database for inoperable cholangiocarcinoma