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

Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Safety (will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0)

Secondary Outcome

 Tumor response as categorized by the World Health Organization criteria at 8 weeks as assessed by ERCP and Intraduct ultrasound

Condition

Cholangiocarcinoma

Intervention

Temoporfin

Study Arms / Comparison Groups

 Foscan
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

March 28, 2014

Completion Date

August 30, 2024

Primary Completion Date

August 30, 2023

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James YW LAU, MD, +85226321411, [email protected]

Location Countries

Hong Kong

Location Countries

Hong Kong

Administrative Informations


NCT ID

NCT03003065

Organization ID

Foscan


Responsible Party

Principal Investigator

Study Sponsor

Chinese University of Hong Kong


Study Sponsor

James YW LAU, MD, Principal Investigator, CUHK


Verification Date

January 2021