Cholangiocarcinoma treatment with radiofrequency ablation or photodynamic therapy

2022-500107-50-00 Protocol CARP Therapeutic use (Phase IV) Ongoing, recruiting

Start 12 Oct 2022 · Status Ongoing, recruiting · 1 EU/EEA countries · 23 sites · Protocol CARP

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 258
Countries 1
Sites 23

hilar cholangiocarcinoma

Does PDT or RFA lead to longer survival?

Key facts

Sponsor
University Of Leipzig
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]
Trial duration
12 Oct 2022 → ongoing
Decision date (initial)
2022-08-24
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2022-500107-50-00
ClinicalTrials.gov
NCT05551299

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Does PDT or RFA lead to longer survival?

Secondary objectives 1

  1. How do quality of life and quality of life adjusted years compare between PDT and RFA? What are the most relevant harms with RFA and PDT and how frequently do they occur?

Conditions and MedDRA coding

hilar cholangiocarcinoma

VersionLevelCodeTermSystem organ class
20.0 LLT 10074878 Hilar cholangiocarcinoma 10029104

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 all trial
The trial consists of only one period.
 Randomised Controlled None PDT: At least one PDT at baseline according to the clinical routine of the trial site.
RFA: At least one RFA at baseline according to the clinical routine of the trial site.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Hilar cholangiocarcinoma (cytological or histological confirmation)
  2. Surgery is not planned
  3. Age 18 or older
  4. Written informed consent

Exclusion criteria 14

  1. Tumour not accessible endoscopically
  2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
  3. Leukopenia (< 2000/mm³)
  4. Thrombocytopenia (< 100,000/mm³)
  5. Severe, uncorrected coagulopathy (at the discretion of the physician)
  6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
  7. Porphyria (clinician’s assessment) or other light-exacerbated diseases
  8. Severely impaired liver and or kidney function (at the discretion of the physician)
  9. Bedridden for more than 50% of the time (similar to ECOG grade 3)
  10. Planned surgical procedure within the next 30 days
  11. Concurrent eye disease that will require a slit lamp examination within the next 30 days
  12. Prior radiotherapy within the last four weeks
  13. Previous PDT or RFA
  14. Planned liver transplantation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint is overall survival, i.e. time from randomization to death from any cause or to the last known date on which the patient was alive. The comparison between arms will be based on the hazard ratio as estimated from a Cox regression model.

Secondary endpoints 7

  1. Overall survival (complementary perspectives)
  2. Days alive and out of hospital up to two years
  3. Quality of Life (QoL) at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value)
  4. Quality-adjusted life years (QALYs)
  5. Stent patency based on clinician’s assessment (e.g. cholangitis, cholestasis, ultrasound)
  6. Laboratory parameters
  7. Pruritus as a function of time up to two years will be considered

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Foscan 1 mg/ml solution for injection

PRD786771 · Product

Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
0.15 mg/Kg milligram(s)/kilogram
Max total dose
0.15 mg/Kg milligram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XD05 — -
Marketing authorisation
EU/1/01/197/005
MA holder
BIOLITEC PHARMA LTD.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP4333212 · ATC

Route of administration
INFUSION
Max daily dose
2 mg/Kg milligram(s)/kilogram
Max total dose
2 mg/Kg milligram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XD01 — PORFIMER SODIUM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Leipzig

5 Total trials 3 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
University Of Leipzig
Address
Haertelstrasse 16-18, Zentrum-Sued Zentrum-Sued
City
Leipzig
Postcode
04107
Country
Germany

Scientific contact point

Organisation
University Of Leipzig
Contact name
Prof. Albrecht Hoffmeister

Public contact point

Organisation
University Of Leipzig
Contact name
Prof. Albrecht Hoffmeister

Locations

1 EU/EEA country · 23 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ongoing, recruiting 258 23
Rest of world — 0 —

Investigational sites

Germany

23 sites · Ongoing, recruiting
Klinikum St. Georg gGmbH
Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie, Delitzscher Strasse 141, Eutritzsch, Leipzig
Universitaetsklinikum Aachen AöR
Medizinische Klinik III, Pauwelsstrasse 30, 52074, Aachen
Vivantes Netzwerk fuer Gesundheit GmbH
Innere Medizin-Gastroenterologie, Landsberger Allee 49, Friedrichshain, Berlin
University Of Leipzig
Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie und Infektiologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitat Heidelberg
Medizinische Fakultät Mannheim der Universität Heidelberg, II. Medizinische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik II, Campus Großhadern, Marchioninistrasse 15, Hadern, Munich
Westfaelische Wilhelms-Universitaet Muenster
Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie), Gebaeude A14, Albert-Schweitzer-Campus 1, Muenster
Klinikum Nuernberg
Klinik für Innere Medizin 5, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Robert-Bosch-Krankenhaus GmbH
Gastroenterologie, Hepatologie und Endokrinologie, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie, Posilipostraße 4, Mitte, Ludwigsburg
Goethe University Frankfurt
Universitätsklinikum Frankfurt, Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Augsburg
III. Med. Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsmedizin Greifswald KöR
Klinik für Innere Medizin A, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik I, Venusberg-Campus 1, Venusberg, Bonn
Medical Center - University Of Freiburg
Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Klinikum Region Hannover GmbH
Klinik für Gastroenterologie, Interventionelle Endoskopie, Diabetologie und Akutgeriatrie, Stadionbruecke 4, Linden-Sued, Hanover
Martin-Luther-Universitat Halle-Wittenberg
Universitätsklinik und Poliklinik für Innere Medizin I, Ernst-Grube-Straße 40, Kröllwitz, Halle (saale)
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik I, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Klinikum Hanau GmbH
Medizinische Klinik 2, Leimenstrasse 20, 63450, Hanau
Philipps-Universitaet Marburg
Klinik für Innere Medizin, Baldingerstrasse, 35043, Marburg
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Medizinische Klinik, In Der Schornau 23-25, Langendreer, Bochum
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Klinik für Hämatologie, Onkologie und Palliativmedizin, Stuttgart Cancer Center, Kriegsbergstrasse 60, Mitte, Stuttgart
Universitaetsmedizin Goettingen
Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie, Robert-Koch-Strasse 40, Weende, Goettingen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2022-10-12 2023-02-10

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) CARP_protocol_p 3
Recruitment arrangements (for publication) CARP_recruitment 1
Subject information and informed consent form (for publication) CARP_Subject information and informed consent form 3
Summary of Product Characteristics (SmPC) (for publication) foscan-epar-product-information_de 1
Summary of Product Characteristics (SmPC) (for publication) foscan-epar-product-information_de 1
Summary of Product Characteristics (SmPC) (for publication) Photofrin75mg_2017-10 1
Summary of Product Characteristics (SmPC) (for publication) Photofrin75mg_2017-10 1
Summary of Product Characteristics (SmPC) (for publication) photofrin75mg_2024-04 1
Synopsis of the protocol (for publication) CARP_synopse_German 3

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-05-03 Germany Acceptable
2022-08-22
 2022-08-24
2 SUBSTANTIAL MODIFICATION SM-1 2022-11-21 Germany Acceptable
2023-01-17
 2023-01-19
3 SUBSTANTIAL MODIFICATION SM-2 2023-03-27 Germany Acceptable 2023-05-05
4 SUBSTANTIAL MODIFICATION SM-3 2023-07-13 Germany Acceptable
2023-08-15
 2023-08-16
5 SUBSTANTIAL MODIFICATION SM-4 2024-03-07 Germany Acceptable 2024-04-12
6 SUBSTANTIAL MODIFICATION SM-5 2025-05-21 Germany Acceptable
2025-06-11
 2025-06-16

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