NCT03003065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

9 years

First QC Date

February 24, 2016

Last Update Submit

August 20, 2023

Conditions

CholangiocarcinomaTumorKlatskin Tumor

Keywords

Inoperable cholangiocarcinomaPhotodynamic therapyEndoscopic retrograde cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

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

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

    10 years

Secondary Outcomes (4)

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

    10 years

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

    10 years

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

    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.

    10 years

Study Arms (1)

Foscan

OTHER

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

Interventions

TemoporfinDRUG

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

Also known as: Foscan
Foscan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Centre, Prince of Wales Hospital

Shatin, N.T., Hong Kong

Location

MeSH Terms

Conditions

CholangiocarcinomaNeoplasmsKlatskin Tumor

Interventions

temoporfin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • James YW LAU, MD

    CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2016

First Posted

December 26, 2016

Study Start

March 28, 2014

Primary Completion

April 12, 2023

Study Completion

August 12, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)