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

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ClinicalTrials.gov Identifier: NCT03003065
Recruitment Status : Recruiting
First Posted : December 26, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Tumor Klatskin Tumor Drug: Temoporfin Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tumoricidal Effect of Low Dose Temoporfin Photodynamic Therapy in Patients With Inoperable Bile Duct Cancers (Foscan® Study)
Actual Study Start Date : March 28, 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Foscan
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
Drug: Temoporfin
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
Other Name: Foscan




Primary Outcome Measures :
  1. Safety (will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0) [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Tumor response as categorized by the World Health Organization criteria at 8 weeks as assessed by ERCP and Intraduct ultrasound [ Time Frame: 10 years ]
    Tumor response as categorized by the World Health Organization criteria at 8

  2. Relief of jaundice at 8 weeks (<50% pretreatment serum bilirubin) [ Time Frame: 10 years ]
    Relief of jaundice at 8 weeks (<50% pretreatment serum bilirubin)

  3. Cholangitis and stent occlusions requiring stent change (will be assessed based on blood tests and ERCP findings) [ Time Frame: 10 years ]
    Cholangitis and stent occlusions requiring stent change (will be assessed based on blood tests and ERCP findings)

  4. 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. [ Time Frame: 10 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with inoperable cholangiocarcinoma belonging to all Bismuth Corlette classification.
  • Karnofsky index >30%
  • Satisfactory relief of jaundice (serum bilirubin < 100µmol/L) with biliary prostheses inserted either at ERCP or via percutaneous transhepatic routes.
  • Absence of biliary sepsis
  • Age 18-80
  • Provision of written consent
  • No evidence of metastatic disease

Exclusion Criteria:

  • Porphyria
  • Previous inserted metallic biliary stents
  • Refusal to provide a written consent.
  • Moribund from disseminated disease or comorbidities
  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003065


Contacts
Contact: James YW LAU, MD +85226321411 laujyw@surgery.cuhk.edu.hk
Contact: Kim WL AU, MSc +85226322640 kimau@surgery.cuhk.edu.hk

Locations
Hong Kong
Endoscopy Centre, Prince of Wales Hospital Recruiting
Shatin, N.t., Hong Kong
Contact: Kim WL AU, MSc    +85226322640    kimau@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: James YW LAU, MD CUHK

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03003065     History of Changes
Other Study ID Numbers: Foscan
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Inoperable cholangiocarcinoma
Photodynamic therapy
Endoscopic retrograde cholangiopancreatography

Additional relevant MeSH terms:
Cholangiocarcinoma
Bile Duct Neoplasms
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Temoporfin
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents