Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

NCT02725073 | Unknown Phase 2 DMC

• 1 other identifier: ERCP-PDT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.

Conditions

Treatment Response; Adverse Events; Feasibility

Outcome Measures

Primary Outcomes (1)

• Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria

  Response Evaluation Criteria in Solid Tumours (RECIST) criteria

  within 1 month

Secondary Outcomes (1)

• Adverse events and overall survival

  within 1 week

Study Arms (1)

photodynamic therapy

EXPERIMENTAL

Photodynamic therapy with a novel photosensitizer and flexible laser catheter

Procedure: Photodynamic therapy

Interventions

Photodynamic therapy PROCEDURE

Photolon (Belmedpreparaty, Minsk, Republic of Belarus), was administered intravenously at a dose of 2.5 mg/kg at 3 hours before illumination. After advancing a catheter (7 F inner sheath of a plastic stent delivery catheter \[MAJ-1419; Olympus America, Center Valley, Pa., USA\]) across the biliary stricture using a 0.035-in guidewire, the cylindrical diffuser is inserted into a catheter at the level of the stricture to be treated. Photoactivation (660 nm with a light dose of 100-150J/cm2, and fluence of 0.8-1W/cm2; UPL- FDT; LEMT Research \& Development Private Unitary Enterprise, Minsk, Republic of Belarus) is performed

photodynamic therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection
• Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center
• Pathologically proven cholangiocarcinoma
• have a negative pregnancy test if appropriate
• ECOG(Eastern Cooperative Oncology Group) Score 0-2
• patients to give informed consent and age more than \>19 years

You may not qualify if:

• age less than 18 years
• previous history of PDT
• uncorrectable coagulopathy
• refuse to participate
• pregnancy
• recent participation in another clinical research trial within 30 days
• presence of porphyria or hypersensitivity to photosensitizer
• Creatinine clearance \< 45ml

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (2)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Do Hyun Park

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Photochemotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Do Hyun Park, Md, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Do Hyun Park, MD, PhD

CONTACT

+82-2-3010-32194; dhpark@amc.seoul.kr

Jun Ho Choi, MD

CONTACT

mdcjh78@gmail.com

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: Associate Professor

Study Record Dates

• First Submitted: March 20, 2016
• First Posted: March 31, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (2)