<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03003065</url>
  </required_header>
  <id_info>
    <org_study_id>Foscan</org_study_id>
    <nct_id>NCT03003065</nct_id>
  </id_info>
  <brief_title>Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers</brief_title>
  <acronym>PDT</acronym>
  <official_title>Safety and Tumoricidal Effect of Low Dose Temoporfin Photodynamic Therapy in Patients With Inoperable Bile Duct Cancers (Foscan® Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents&#xD;
      in patients with inoperable bile duct cancers. In addition as a preliminary study we sought&#xD;
      to determine if the treatment can reduce tumor volume in the short term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cholangiocarcinoma is a tumor associated with a grave prognosis. The only curative treatment&#xD;
      is surgery or liver transplantation. Only about 10-20% of patients with the tumor are&#xD;
      operated upon. In the majority of patients, the tumor is often diagnosed at a late stage.&#xD;
      Many patients are not operated upon owing to their advanced age or comorbid illnesses. These&#xD;
      patients suffer from intense pruritus a result of obstructive jaundice, recurrent biliary&#xD;
      sepsis and progressive hepatic failure leading to death. Quality in life in these patients is&#xD;
      poor. The median survival in these patients is around 6 months. The palliative treatment is&#xD;
      stents inserted either at ERCP or through a percutaneous transhepatic route. Many return with&#xD;
      recurrent cholangitis necessitating frequent stent changes. Photodynamic therapy (PDT) in&#xD;
      combination with stenting is the only proven treatment that confers a survival benefit when&#xD;
      compared to stenting alone. Two randomized controlled trials have shown significant survival&#xD;
      advantage in patients treated by PDT in addition to stenting compared to stenting alone.&#xD;
      Ortner et al. 1 randomized 39 patients with inoperable cholangiocarinoma to endoscopic stents&#xD;
      with or without PDT. Median survival in those given PDT was 493 days compared to that of 98&#xD;
      days in those with stents alone. Survival difference was again wide in favor of PDT use in&#xD;
      another randomized controlled study by Zoepf et al 2 (median survival 630 vs. 210 days). In&#xD;
      addition, PDT improves quality of life and cholestasis in patients with cholangiocarcinoma.&#xD;
      In a series from Germany, survival after PDT and stenting compared favorably to R1 and R2&#xD;
      resections. 3 Despite of the evidence, PDT for inoperable cholangiocarcinoma is not available&#xD;
      in Hong Kong.&#xD;
&#xD;
      Meso-tetrahydroxyphenylchlorin (mTHPC, Foscan®) is a photosensitizer for PDT in&#xD;
      cholangiocarcinoma. In compared with other agents such as Photofin and Photosan, PDT&#xD;
      treatment using temoporfin at a low dose (3 mg per treatment) is associated with a deeper&#xD;
      tissue penetration (4-6mm) and a reduced period of photosensitivity.&#xD;
&#xD;
      In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents&#xD;
      in patients with inoperable bile duct cancers. In addition as a preliminary study we sought&#xD;
      to determine if the treatment can reduce tumor volume in the short term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2014</start_date>
  <completion_date type="Actual">August 12, 2023</completion_date>
  <primary_completion_date type="Actual">April 12, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety (will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0)</measure>
    <time_frame>10 years</time_frame>
    <description>Safety (will be graded according to the Common Terminology Criteria for Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor response as categorized by the World Health Organization criteria at 8 weeks as assessed by ERCP and Intraduct ultrasound</measure>
    <time_frame>10 years</time_frame>
    <description>Tumor response as categorized by the World Health Organization criteria at 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relief of jaundice at 8 weeks (&lt;50% pretreatment serum bilirubin)</measure>
    <time_frame>10 years</time_frame>
    <description>Relief of jaundice at 8 weeks (&lt;50% pretreatment serum bilirubin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholangitis and stent occlusions requiring stent change (will be assessed based on blood tests and ERCP findings)</measure>
    <time_frame>10 years</time_frame>
    <description>Cholangitis and stent occlusions requiring stent change (will be assessed based on blood tests and ERCP findings)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>10 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Cholangiocarcinoma</condition>
  <condition>Tumor</condition>
  <condition>Klatskin Tumor</condition>
  <arm_group>
    <arm_group_label>Foscan</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temoporfin</intervention_name>
    <description>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</description>
    <arm_group_label>Foscan</arm_group_label>
    <other_name>Foscan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with inoperable cholangiocarcinoma belonging to all Bismuth Corlette&#xD;
             classification.&#xD;
&#xD;
          -  Karnofsky index &gt;30%&#xD;
&#xD;
          -  Satisfactory relief of jaundice (serum bilirubin &lt; 100µmol/L) with biliary prostheses&#xD;
             inserted either at ERCP or via percutaneous transhepatic routes.&#xD;
&#xD;
          -  Absence of biliary sepsis&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  Provision of written consent&#xD;
&#xD;
          -  No evidence of metastatic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Porphyria&#xD;
&#xD;
          -  Previous inserted metallic biliary stents&#xD;
&#xD;
          -  Refusal to provide a written consent.&#xD;
&#xD;
          -  Moribund from disseminated disease or comorbidities&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James YW LAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CUHK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endoscopy Centre, Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <state>N.t.</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>August 20, 2023</last_update_submitted>
  <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>James Yun-wong Lau</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Inoperable cholangiocarcinoma</keyword>
  <keyword>Photodynamic therapy</keyword>
  <keyword>Endoscopic retrograde cholangiopancreatography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Bile Duct Neoplasms</mesh_term>
    <mesh_term>Klatskin Tumor</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temoporfin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003065
org study id: Foscan
nct id: NCT03003065
lead sponsor: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety (will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0)
time frame: 10 years
description: Safety (will be graded according to the Common Terminology Criteria for Adverse Events
measure: Tumor response as categorized by the World Health Organization criteria at 8 weeks as assessed by ERCP and Intraduct ultrasound
time frame: 10 years
description: Tumor response as categorized by the World Health Organization criteria at 8
measure: Relief of jaundice at 8 weeks (<50% pretreatment serum bilirubin)
time frame: 10 years
description: Relief of jaundice at 8 weeks (<50% pretreatment serum bilirubin)
measure: Cholangitis and stent occlusions requiring stent change (will be assessed based on blood tests and ERCP findings)
time frame: 10 years
description: Cholangitis and stent occlusions requiring stent change (will be assessed based on blood tests and ERCP findings)
measure: 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
description: 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.
arm group label: Foscan
arm group type: Other
description: 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
intervention type: Drug
intervention name: Temoporfin
description: 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
arm group label: Foscan
other name: Foscan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James YW LAU, MD
role: Principal Investigator
affiliation: CUHK
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: James Yun-wong Lau
investigator title: Professor
mesh term: Cholangiocarcinoma
mesh term: Bile Duct Neoplasms
mesh term: Klatskin Tumor
mesh term: Temoporfin
sharing ipd: No