Photodynamic Therapy in Locally Advanced Hilar Cholangioc... | NCT02725073

Studies
Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

NCT02725073

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

Apr 14, 2016Estimated

Enrollment

32Estimated

Phase

Phase 2

Conditions

Treatment Response
Adverse Events
Feasibility

Interventions

Photodynamic therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 20, 2016

First Submission Date that Met QC Criteria

Mar 30, 2016

First Posted Date

Mar 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2016

Last Update Posted Date

Apr 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Photodynamic therapy (PDT) is a way of producing tissue necrosis with light after prior administration of a photosensitizing agent. The most important advantages include the possibility of combining PDT with other target therapies and repeat the process as needed with a favorable outcomes. The combination of diverse therapeutic modalities is one of the new strategies to enhance oncologic treatments for pancreatic cancer. In order to overcome the limitations of each treatment modalities and to prevent the development of resistance, the application of PDT combined with target therapies, without increasing the toxicity for the patient, is being widely investigated.

PDT has been only extensively studied for the treatment of various superficial skin cancers in the Europe but not available in the United States and Japan due to the overlapping treatment fields. In Korea, the use of first-generation and second-generation photosensitizers are part of the study of Gastroenterology, Dermatology, Otolaryngology, and Gynecology.

Recently, although the investigators have introduced PDT using novel photosensitizers has not yet been used for the treatment of pancreatic cancers. This study aim to determine the safety and efficacy of photodynamic therapy with a novel photosensitizer in locally advanced hilar cholangiocarcinoma.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
photodynamic therapy	Experimental	Photodynamic therapy with a novel photosensitizer and flexible laser catheter	Procedure: Photodynamic therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Adverse events and overall survival	any procedural adverse events and overall survival	within 1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Do Hyun Park, MD, PhD	Contact	+82-2-3010-32194		dhpark@amc.seoul.kr
Jun Ho Choi, MD	Contact			mdcjh78@gmail.com

Overall Officials

Name	Affiliation	Role
Do Hyun Park, Md, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul		138-736	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010778	Photochemotherapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D010789	Phototherapy

Browse Leaves

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Browse Branches

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