Hilar CholangiocarcinomaPhase 4CARPNCT05551299
Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
A Phase 4 study testing Photosensitizer and Radiofrequency ablation (RFA) in people with Hilar Cholangiocarcinoma, run by University of Leipzig at 20 sites in Germany.
Trial summary
Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hilar Cholangiocarcinoma
- What is being tested?
- Photosensitizer and Radiofrequency ablation (RFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 20 sitesGermany
- Study dates
- 10 Feb 2023to Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hilar cholangiocarcinoma (cytological or histological confirmation)
- Surgery is not planned
- Age ≥ 18 years
- Written informed consent
Who cannot join
- Tumour not accessible endoscopically
- Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
- Leukopenia (< 2000/mm3)
- Thrombocytopenia (< 100,000 / mm³)
- Severe, uncorrected coagulopathy (at the discretion of the physician)
- Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
Show all 18Show fewer
- Porphyria (clinician's assessment) or other light-exacerbated diseases
- Severely impaired liver and or kidney function (at the discretion of the physician)
- Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)
- Planned surgical procedure within the next 30 days
- Concurrent eye disease that will require a slit lamp examination within the next 30 days
- Prior radiotherapy within the last four weeks
- Previous PDT or RFA
- Planned liver transplantation
- Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception)
- Participation in other interventional trials
- Patients under legal supervision or guardianship
- Pregnant or nursing women
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Albrecht Hoffmeister, Prof.Dr.med. contact
20 sites in 1 country
Germany20 sites, 19 recruiting
- Recruiting
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, 52074
Karim Hamesch, PD Dr., +49 241 80 80861, khamesch@ukaachen.de
- Recruiting
Universitätsklinikum Augsburg; III. Med. Klinik
Augsburg, 86156
Tobias Weber, Dr., tobias.weber@uk-augsburg.de
- Not yet recruiting
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
Berlin, 10249
Thomas Brunk, Dr., thomas.brunk@vivantes.de
- Recruiting
Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, 53127
Dominik Kaczmarek, Dr., +49 228 287 -15263, Dominik.Kaczmarek@ukbonn.de
- Not yet recruiting
Universitätsklinikum Frankfurt, Medizinische Klinik 1
Frankfurt, 60590
Jörg Trojan, Prof. Dr.
- Recruiting
Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
Freiburg im Breisgau, 79106
Armin Küllmer, Dr.
- Recruiting
Universitätsmedizin Greifswald Klinik für Innere Medizin A
Greifswald, 17475
Ali Aghdassi, Prof., Ali.Aghdassi@med.uni-greifswald.de
- Recruiting
Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Halle, 06120
Jonas Rosendahl, Prof. Dr., +49 345 557 2661, jonas.rosendahl@uk-halle.de
- Recruiting
Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie
Hanau, 63450
Likas Welsch, Dr., Lukas_Welsch@klinikum-hanau.de
- Recruiting
KRH Klinikum Siloah, Klinik für Gastroenterologie
Hanover, 30459
Daniel Vidacek, Dr., +49 511 927 2102, Daniel.Vidacek@krh.de
- Recruiting
Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie
Leipzig, 04109
Ingolf Schiefke, Prof., ingolf.schiefke@SanktGeorg.de
- Recruiting
University Hospital of Leipzig, Department of Gastroenterology
Leipzig
Albrecht Hoffmeister, Prof. Dr., ++49 - 341 - 97 12240, Albrecht.Hoffmeister@medizin.uni-leipzig.de
- Recruiting
RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
Ludwigsburg, 71640
Andreas Wannhoff, Dr., +4971419967201, andreas.wannhoff@rkh-kliniken.de
- Withdrawn
Universitätsmedizin Mannheim, II. Medizinische Klinik
Mannheim, 68167
- Recruiting
Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
Marburg, 35043
Ulrike Denzer, Prof., ulrike.denzer@uk-gm.de
- Recruiting
Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern
München, 81377
Jörg Schirra, Prof. Dr., +49 89 4400 73031, joerg.schirra@med.uni-muenchen.de
- Recruiting
Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)
Münster, 48149
Jonel Trebicka, Prof., +492518343330, Jonel.Trebicka@ukmuenster.de
- Recruiting
Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie
Nuremberg, 90419
Alexander Dechêne, Prof., Alexander.Dechene@klinikum-nuernberg.de
- Recruiting
Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie
Stuttgart, 70376
Arthur Schmidt, arthur.schmidt@rbk.de
- Recruiting
Universitätsklinikum Tübingen, Medizinische Klinik I
Tübingen, 72076
Christoph Werner, Dr., +49 7071 2982712, christoph.werner@med.uni-tuebingen.de
About this study
Official title: Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which light of a particular wavelength is applied endoscopically to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat, also applied endoscopically. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with a particular bile duct cancer depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.
Read the detailed description
Klatskin tumours are a form of bile duct cancer. They are generally not diagnosed until quite late and a curative operation is rarely a possibility. Their anatomic location usually results in bile duct obstruction and the aim of therapy is thus to keep the ducts open. This is accomplished through endoscopic retrograde cholangiopancreatography (ERCP) by implanting stents. Stent therapy combined with photodynamic therapy (PDT) extends life expectancy. PDT requires an injection of photosensitizer that is absorbed primarily by the cancer cells. Light of a particular wavelength is then applied with ERCP to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat applied during ERCP. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with Klatskin tumours depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.
- Conditions
- Hilar Cholangiocarcinoma
- Being tested
- Photosensitizer, Radiofrequency ablation (RFA)
- Keywords
- Hilar Cholangiocarcinoma, Radiofrequency ablation (RFA), Photodynamic therapy (PDT), Photosensitizer, Klatskin Tumor, Bile Duct Cancer
- Medical subject headings
- Klatskin Tumor, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotosensitizerDrug
Also called Photodynamic therapy (PDT)
A photosensitizer, which is absorbed preferentially by tumour cells, is administered 24 - 48 hours prior to PDT. Light of a particular wavelength is then applied during endoscopic retrograde cholangiopancreatography (ERCP) to kill primarily cancer cells locally within the stenosis. Immediately after PDT treatment, new stents are inserted into all treated segments if needed.
Radiofrequency ablation (RFA)Procedure or surgery
RFA is also carried out as part of an ERCP. The RFA-probe is placed within the tumour stenosis and electrical current is applied. New stents are inserted into all treated segments if needed.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy (PDT) | Experimental | The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one PDT at baseline according to the clinical routine of the trial site. Receives: Drug: Photosensitizer |
| Radiofrequency ablation (RFA) | Experimental | The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one RFA at baseline according to the clinical routine of the trial site. Receives: Procedure: Radiofrequency ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Hazard ratio from a Cox regression model will be used to compare randomization arms. Covariates will be stratification variables, classification of local inoperability, use of prophylactic antibiotics, Bismuth type and time between diagnosis and beginning RFA/PDT.
Measured: through study completion, an average of 1 year
Secondary outcomes (18)
Overall survival (complementary perspective: median survival time)
Estimates of the difference in median survival time between the groups will be based on the method of Chen and Zhang (PMID: 26983640).
Measured: through study completion, an average of 1 year
Overall survival (complementary perspective: two-year overall survival)
Kaplan-Meier estimates will be used.
Measured: up to two years
Overall survival (complementary perspective: restricted mean survival on a time horizon of two-years)
Kaplan-Meier estimates will be used (see e.g. PMID: 15690989)
Measured: through study completion, an average of 1 year
Days alive and out of hospital up to two years
This constitutes a basic and easy to understand measure of quality of life. Only in-hospital stays will be included in this endpoint and the day of arrival and dismissal will each be counted. The source of data will be the hospital records, epicrisis and patient disclosure.
Measured: up to two years
Quality of Life (QoL) measured using QLQ-C30 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)
Prolonging life is especially worthwhile if QoL is sufficiently good. The established cancer-specific Core Quality of Life questionnaire QLQ-C30 from the EORTC (European Organisation for Research will be used. Shortly after the index therapy (V2, V3), the difference between arms will be assessed. The requirement to stay indoors may affect QoL. At later points in time, a description per arm is of interest and will be based on a weighted mean of all available questionnaires, weighting according to calendar time.
Measured: through study completion, an average of 1 year
Quality of Life (QoL) measured using FACT-Hep 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)
Prolonging life is especially worthwhile if QoL is sufficiently good. The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) questionnaire, containing the hepatobiliary-specific cancer subscale, will be used as a second instrument for assessing QoL. Shortly after the index therapy (V2, V3), the difference between arms will be assessed. The requirement to stay indoors may affect QoL. At later points in time, a description per arm is of interest and will be based on a weighted mean of all available questionnaires, weighting according to calendar time.
Measured: through study completion, an average of 1 year
Quality-adjusted life years (QALYs)
Using QALYs, a weighted measure of survival will be compared between RFA and PDT that takes QoL into account. The details will be provided in a Statistical Analysis Plan.
Measured: through study completion, an average of 1 year
Stent patency based on clinician's assessment (e.g. cholangitis, cholestasis, ultrasound)
Stent patency provides one measure of the burden of the disease and efficacy of the treatment. Mean time to stent closure/replacement/death after last stent replacement will be analysed.
Measured: through study completion, an average of 1 year
Laboratory parameter (leucocytes)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (haematocrit)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (haemoglobin)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (bilirubin)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (albumin)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (CA 19-9)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (CRP)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (ALT)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Laboratory parameter (GGT)
Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.
Measured: through study completion, an average of 1 year
Pruritus as reported by patients on a scale from 0 ("no itching") to 10 ("worst imaginable itching").
Pruritus will be analysed as a function of time.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start10 Feb 2023
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hilar CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Zentrum für Klinische Studien Leipzig
- Responsible party
- Principal investigator, Albrecht Hoffmeister, University of Leipzig
- Investigators
- Albrecht Hoffmeister, Prof.Dr.med., Principal investigator, Universitätsklinikum Leipzig; Bereich Gastroenterologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551299
- Sponsor's protocol ID
- CARP
- Other IDs
- 2022-500107-50-00, 434336116
- Acronym
- CARP
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05551299
- Acronym / sponsor ID
- CARP / CARP
- Conditions
- Hilar Cholangiocarcinoma
- Keywords
- Hilar Cholangiocarcinoma, Radiofrequency ablation (RFA), Photodynamic therapy (PDT), Photosensitizer, Klatskin Tumor, Bile Duct Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Zentrum für Klinische Studien Leipzig
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which light of a particular wavelength is applied endoscopically to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat, also applied endoscopically. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with a particular bile duct cancer depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.
Detailed description
Klatskin tumours are a form of bile duct cancer. They are generally not diagnosed until quite late and a curative operation is rarely a possibility. Their anatomic location usually results in bile duct obstruction and the aim of therapy is thus to keep the ducts open. This is accomplished through endoscopic retrograde cholangiopancreatography (ERCP) by implanting stents. Stent therapy combined with photodynamic therapy (PDT) extends life expectancy. PDT requires an injection of photosensitizer that is absorbed primarily by the cancer cells. Light of a particular wavelength is then applied with ERCP to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat applied during ERCP. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with Klatskin tumours depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy (PDT) | Experimental | Drug: PhotosensitizerThe index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one PDT at baseline according to the clinical routine of the trial site. |
| Radiofrequency ablation (RFA) | Experimental | Procedure: Radiofrequency ablation (RFA)The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one RFA at baseline according to the clinical routine of the trial site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hilar cholangiocarcinoma (cytological or histological confirmation)
- Surgery is not planned
- Age ≥ 18 years
- Written informed consent
Key exclusion criteria (18 listed)
- Tumour not accessible endoscopically
- Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
- Leukopenia (< 2000/mm3)
- Thrombocytopenia (< 100,000 / mm³)
- Severe, uncorrected coagulopathy (at the discretion of the physician)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotosensitizerAlso: Photodynamic therapy (PDT)A photosensitizer, which is absorbed preferentially by tumour cells, is administered 24 - 48 hours prior to PDT. Light of a particular wavelength is then applied during endoscopic retrograde cholangiopancreatography (ERCP) to kill primarily cancer cells locally within the stenosis. Immediately after PDT treatment, new stents are inserted into all treated segments if needed. | Drug | Photodynamic therapy (PDT) |
| Radiofrequency ablation (RFA)RFA is also carried out as part of an ERCP. The RFA-probe is placed within the tumour stenosis and electrical current is applied. New stents are inserted into all treated segments if needed. | Procedure or surgery | Radiofrequency ablation (RFA) |
Primary outcome
Overall survival
Time frame: through study completion, an average of 1 year
Hazard ratio from a Cox regression model will be used to compare randomization arms. Covariates will be stratification variables, classification of local inoperability, use of prophylactic antibiotics, Bismuth type and time between diagnosis and beginning RFA/PDT.
18 secondary outcomes
Overall survival (complementary perspective: median survival time)
Time frame: through study completion, an average of 1 year
Overall survival (complementary perspective: two-year overall survival)
Time frame: up to two years
Overall survival (complementary perspective: restricted mean survival on a time horizon of two-years)
Time frame: through study completion, an average of 1 year
Days alive and out of hospital up to two years
Time frame: up to two years
Quality of Life (QoL) measured using QLQ-C30 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)
Time frame: through study completion, an average of 1 year
Quality of Life (QoL) measured using FACT-Hep 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)
Time frame: through study completion, an average of 1 year
Quality-adjusted life years (QALYs)
Time frame: through study completion, an average of 1 year
Stent patency based on clinician's assessment (e.g. cholangitis, cholestasis, ultrasound)
Time frame: through study completion, an average of 1 year
Laboratory parameter (leucocytes)
Time frame: through study completion, an average of 1 year
Laboratory parameter (haematocrit)
Time frame: through study completion, an average of 1 year
Laboratory parameter (haemoglobin)
Time frame: through study completion, an average of 1 year
Laboratory parameter (bilirubin)
Time frame: through study completion, an average of 1 year
Laboratory parameter (albumin)
Time frame: through study completion, an average of 1 year
Laboratory parameter (CA 19-9)
Time frame: through study completion, an average of 1 year
Laboratory parameter (CRP)
Time frame: through study completion, an average of 1 year
Laboratory parameter (ALT)
Time frame: through study completion, an average of 1 year
Laboratory parameter (GGT)
Time frame: through study completion, an average of 1 year
Pruritus as reported by patients on a scale from 0 ("no itching") to 10 ("worst imaginable itching").
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Hilar Cholangiocarcinoma
Active, not recruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
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Active, not recruitingPhase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Biliary Tract Cancer
Recruiting
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Perihilar Cholangiocarcinoma, Klatskin Tumor
RecruitingPhase 2
Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Cholangiocarcinoma, Hilar Cholangiocarcinoma
Recruiting
Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
Cholangiocarcinoma, Bile Duct Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albrecht Hoffmeister, Prof.Dr.med. contact
Albrecht Hoffmeister, Prof.Dr.med. principal investigator
Universitätsklinikum Leipzig; Bereich Gastroenterologie
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Photosensitizer and Radiofrequency ablation (RFA) in people with Hilar Cholangiocarcinoma, run by University of Leipzig at 20 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albrecht Hoffmeister, Prof.Dr.med. (+49-341-97-12240, albrecht.hoffmeister@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.