Bile Duct CancerPhase 2AblatioNCT06274879
Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer
A Phase 2 study testing Gemcitabin, Cisplatin and Durvalumab, Biliary Radiofrequency Ablation and Endoscopic Retrograde Cholangio-Pancreatography with stenting in people with Bile Duct Cancer, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
Trial summary
The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Cancer
- What is being tested?
- Gemcitabin, Cisplatin and Durvalumab, Biliary Radiofrequency Ablation and Endoscopic Retrograde Cholangio-Pancreatography with stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 20 May 2026to 30 Dec 2030
- Phase
- Phase 2
- 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
- Male or female ≥18 years old.
- Histologically or cytologically confirmed diagnosis of previously untreated and unresectable*, locally advanced and/or metastatic extrahepatic biliary tract cholangiocarcinoma with obstructive jaundice (increased serum level of total bilirubin).
- ECOG performance status 0 to 2.
- Adequate bone marrow function: Neutrophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L.
- Adequate renal function in case of cisplatin administration: Estimated Glomerular Filtration Rate (eGFR) ≥60mL/min/1.73m2.
- Willing and able to provide written informed consent.
Show all 40Show fewer
- Planned initiation of any standard-of-care systemic anti-proliferative therapy against ETB.
- The reason for inoperability needs to be documented and categorized as follows:
- Wish of patient.
- Locally advanced or vascular invasion = surgically not removable.
- Remnant liver is not sufficient.
- Anatomic contraindications.
- Distant metastasis.
- Severe comorbidities.
- Other reasons. Exclusion criteria
- <!-- -->
- Solely intrahepatic cholangiocarcinoma or mixed type liver tumors (cholangiocarcinoma with hepatocellular differentiation parts).
- Multiple hepatic metastases with significant blockage of one or more liver segments and/or less than 50% of liver parenchyma potentially drainable on pre-intervention imaging.
- In case of immune-checkpoint-inhibitor (ICI) administration, any autoimmune diseases including inflammatory disorders such as Crohn's disease, ulcerative colitis, Wegener granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease.
- Exceptions:
- Hypothyroidism following Hashimoto thyroiditis stable on hormone replacement.
- Patients with vitiligo.
- Any chronic skin disorders that do not require systemic treatment.
- Use of immunosuppressive medication within 3 weeks prior to ICI administration.
- Exceptions:
- Topical or inhaled steroids.
- Systemic corticosteroids at physiologic doses not exceeding >10mg/d of prednisone or equivalent.
- Prior Self-Expandable Metal Stent (SEMS) placement in the biliary tree.
- Biliary obstruction of non-tumoral etiology.
- Platelets <100 x 109/L or International Normalized Ratio (INR) >1.5.
- Secondary tumor.
- Exceptions:
- Tumor treated with curative intent without recurrence for more than 5 years.
- Non-melanoma skin cancer treated carcinoma in situ without evidence of disease.
- Pregnancy or lactation.
- Known or suspected non-compliance, drug, or alcohol abuse.
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the candidate.
- Participation in another interventional study within 30 days prior to enrollment.
- Previous participation in the current study.
- Other diseases like Human Immunodeficiency Virus, Liver cirrhosis Child-Pugh B or C, cardiac pacemaker, history of organ transplantation or condition likely to significantly decrease life expectancy i.e., life expectancy is less than 3 months according to investigator judgement.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Inselspital Bern University Hospital
Bern, 3010
Prof. Dr. med. Reiner Wiest, +41 31 632 59 41, reiner.wiest@insel.ch
Prof. Dr. med. Martin Berger, +41 31 632 41 14, martin.berger@insel.ch
- Not yet recruiting
Hôpitaux Universitaires Genève
Geneva, 1205
Pr Jean-Louis Frossard, +41 22 372 93 40, jean-louis.frossard@hug.ch
Dr. Thibaud Koessler
- Not yet recruiting
Luzerner Kantonspital
Lucerne, 6004
Dr. med. Simon Bütikofer, +41 41 205 6966, simon.buetikofer@luks.ch
Dr. med. Ralph Winterhalder
- Not yet recruiting
Universitätsspital Zürich
Zurich, 8091
PD Dr. med. Christoph Schlag, +41 44 253 13 70, christoph.schlag@usz.ch
PD Dr. med. Ralph Fritsch
About this study
Official title: Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer (EBTC) Undergoing Systemic Anti-tumor Therapy: a Phase II, Multi-center, Randomized, and Controlled Study (Ablatio-bilica)
The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). The main question it aims to answer is whether it is safe to combine systemic anti-tumor therapy with or without ICI with and bRFA.
Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and systemic anti-tumor therapy, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.
Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.
Read the detailed description
Extrahepatic biliary tract cancer (EBTC) in most cases is diagnosed at an unresectable stage of disease. Standard-of-care systemic palliative treatment consists of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). Nonetheless, overall survival remains limited at about 12.8 months. Moreover, severe adverse events can occur leading to treatment discontinuation increasing the risk of tumor progression and poor prognosis. Biliary obstruction is one of the most relevant factors for survival limiting eligibility and timing/dosing of chemo-(immuno)therapy. Endoscopic biliary stenting is standard to relieve jaundice, but tumor ingrowth can limit the rate and duration of success. Radiofrequency ablation (RFA) results from thermal damage created by a high-frequency alternating current released from an electrode into tissue. RFA has become a standard treatment modality in numerous indications, including the treatment of Barrett's oesophagus-related dysplasia and hepatocellular carcinoma. Intraductal biliary radiofrequency ablation (bRFA) is a relatively new method of inducing tumor necrosis via thermal energy. bRFA has been applied in patients suffering unresectable EBTC within randomized-controlled trials indicating improved stent patency as well as overall survival and progression-free survival.
The primary objective of the study is to provide evidence for the general tolerability of bRFA in patients with unresectable extrahepatic biliary tract cholangiocarcinoma undergoing systemic anti-tumor therapy with or without ICI. It is hypothesized that bRFA is generally safe and well tolerated by patients. Primary endpoint of the study is any grade 3 or 4 adverse events leading to chemo-immune checkpoint inhibitor-therapy discontinuation up to six months after enrolment.
Eligible patients will be registered in the study database and randomized in 1:2 ratio to either the standard group (systemic anti-tumor therapy with or without ICI with endoscopic biliary stenting) or the experimental bRFA group (systemic anti-tumor therapy with or without ICI with endoscopic biliary stenting + bRFA).
Systemic anti-tumor therapy with or without ICI with endoscopic biliary stenting are standard of care applied commonly in both the control and the experimental group:
Endoscopic retrograde cholangiography (ERC) procedure stenting are applied at baseline and as clinically indicated. E.g., CICI cycles (Gemcitabin d1 \& d8, Cisplatin d1 \& d8, Durvalumab d1) are administered repeating every 21 days for a total of 8 cycles.
bRFA will be applied only to the experimental group, it is standardized as for generator settings and protocol adapting to tumor morphology using the probe at baseline, 6 and 12 weeks after study start.
- Conditions
- Bile Duct Cancer
- Being tested
- Gemcitabin, Cisplatin and Durvalumab, Biliary Radiofrequency Ablation, Endoscopic Retrograde Cholangio-Pancreatography with stenting
- Keywords
- Durvalumab + chemotherapy, Radiofrequency ablation, Adverse events, Chemo-immune-checkpoint-inhibitor, Extra hepatic biliary tract cancer
- Medical subject headings
- Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabin, Cisplatin and DurvalumabDrug
CICI (Gemcitabin d1 \& d8 Cisplatin d1 \& d8, Durvalumab d1) are administered repeating every 21 days for a total of 8 cycles.
Biliary Radiofrequency AblationProcedure or surgery
Biliary Radiofrequency Ablation is applied at baseline, 6 and 12 weeks
Endoscopic Retrograde Cholangio-Pancreatography with stentingProcedure or surgery
ERCP with stenting are applied at baseline and as clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Standard of care consisting of chemotherapy + durvalumab + endoscopic stenting Receives: Drug: Gemcitabin, Cisplatin and Durvalumab; Procedure: Endoscopic Retrograde Cholangio-Pancreatography with stenting |
| Biliary radiofrequency ablation | Experimental | Standard of care consisting of chemotherapy + durvalumab + endoscopic stenting plus intraductal radiofrequency ablation (bRFA) Receives: Drug: Gemcitabin, Cisplatin and Durvalumab; Procedure: Biliary Radiofrequency Ablation; Procedure: Endoscopic Retrograde Cholangio-Pancreatography with stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any grade 3 or 4 adverse events (AE) leading to systemic anti-tumor therapy with or without ICI discontinuation up to six months after randomization.
AEs will be assessed according to US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5). Treatment discontinuation is defined as deferral of administration by at least four weeks or a definite stop of all systemic anti-tumor therapy with or without ICI agents.
Measured: 6 months
Secondary outcomes (11)
Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions
Current guideline definitions for cholangitis, post-ERCP pancreatitis and bleeding are applied. The rate of readmissions for biliary complications will be assessed specifically by being defined as any non-elective endoscopic reintervention after the first stent placement and will be documented in terms of timing, type of intervention, hospitalization and its duration and resolution.
Measured: 6 months
Progression-free survival: The time until either progression of the underlying disease or death, whichever occurs first, assessed from the time of up to 6 months after randomization.
Measured: 6 months
Death from any cause at the follow-up at 6 months after randomization (overall survival).
Measured: 6 months
Disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle and at 3 and 6 months after the start of CICI treatment.
EORTC QLQ-BIL21 (European Organisation for Research and Treatment of Cancer questionnaire for measuring quality of life in patients with cholangiocarcinoma and cancer of the gallbladder), scores range from 0 to 100, where a lower score means a better quality of life.
Measured: 6 months
Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C30
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer questionnaire quality of life questionnaire core 30), scores range from 0 to 100, where a high scale score represents a higher response level.
Measured: 6 months
Stent patency at month 3 visit and at 6 months after the start of CICI treatment.
Measured: 6 months
Number of courses of CICI applied
Measured: 6 months
Total dose of CICI applied
Measured: 6 months
Number of patients with any grade 3 or 4 Adverse Events (AE) leading to discontinuation or non-initiation of CICI up to six months after randomization.
Measured: 6 months
Number of patients not starting CICI within 4 weeks after randomization.
Measured: 6 months
Time from randomization to CICI start.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start20 May 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cancer League
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Reiner Wiest, Principal investigator, Inselspital Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274879
- Sponsor's protocol ID
- 1938 Ablatio-bilica
- Other IDs
- SNCPT
- Acronym
- Ablatio
- Status last verified
- May 2026
- First submitted
- 7 Feb 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be planned only at study completion
Publications
Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.
PubMed 37075781Rimini M, Fornaro L, Lonardi S, Niger M, Lavacchi D, Pressiani T, Lucchetti J, Giordano G, Pretta A, Tamburini E, Pirrone C, Rapposelli IG, Diana A, Martinelli E, Garajova I, Simionato F, Schirripa M, Formica V, Vivaldi C, Caliman E, Rizzato MD, Zanuso V, Nichetti F, Angotti L, Landriscina M, Scartozzi M, Ramundo M, Pastorino A, Daniele B, Cornara N, Persano M, Gusmaroli E, Cerantola R, Salani F, Ratti F, Aldrighetti L, Cascinu S, Rimassa L, Antonuzzo L, Casadei-Gardini A. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real-world data. Liver Int. 2023 Aug;43(8):1803-1812. doi: 10.1111/liv.15641.
PubMed 37452505Pfister T, Chan SCW, Trelle S, Butikofer S, Winterhalder R, Koessler T, Schlag C, Fritsch R, Frossard JL, Moser A, Berger MD, Wiest R. Ablatio-bilica: safety of biliary intraductal radiofrequency ablation in patients with unresectable extrahepatic biliary tract cancer undergoing systemic anti-tumor therapy: a phase II, multi-center, randomized, and controlled study. Front Oncol. 2026 Feb 24;15:1576401. doi: 10.3389/fonc.2025.1576401. eCollection 2025.
PubMed 41816011
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer (EBTC) Undergoing Systemic Anti-tumor Therapy: a Phase II, Multi-center, Randomized, and Controlled Study (Ablatio-bilica)
- ClinicalTrials.gov ID
- NCT06274879
- Acronym / sponsor ID
- Ablatio / 1938 Ablatio-bilica
- Conditions
- Bile Duct Cancer
- Keywords
- Durvalumab + chemotherapy, Radiofrequency ablation, Adverse events, Chemo-immune-checkpoint-inhibitor, Extra hepatic biliary tract cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss Cancer League
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 23 Feb 2024 (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.
The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). The main question it aims to answer is whether it is safe to combine systemic anti-tumor therapy with or without ICI with and bRFA.
Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and systemic anti-tumor therapy, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.
Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.
Detailed description
Extrahepatic biliary tract cancer (EBTC) in most cases is diagnosed at an unresectable stage of disease. Standard-of-care systemic palliative treatment consists of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). Nonetheless, overall survival remains limited at about 12.8 months. Moreover, severe adverse events can occur leading to treatment discontinuation increasing the risk of tumor progression and poor prognosis. Biliary obstruction is one of the most relevant factors for survival limiting eligibility and timing/dosing of chemo-(immuno)therapy. Endoscopic biliary stenting is standard to relieve jaundice, but tumor ingrowth can limit the rate and duration of success. Radiofrequency ablation (RFA) results from thermal damage created by a high-frequency alternating current released from an electrode into tissue. RFA has become a standard treatment modality in numerous indications, including the treatment of Barrett's oesophagus-related dysplasia and hepatocellular carcinoma. Intraductal biliary radiofrequency ablation (bRFA) is a relatively new method of inducing tumor necrosis via thermal energy. bRFA has been applied in patients suffering unresectable EBTC within randomized-controlled trials indicating improved stent patency as well as overall survival and progression-free survival.
The primary objective of the study is to provide evidence for the general tolerability of bRFA in patients with unresectable extrahepatic biliary tract cholangiocarcinoma undergoing systemic anti-tumor therapy with or without ICI. It is hypothesized that bRFA is generally safe and well tolerated by patients. Primary endpoint of the study is any grade 3 or 4 adverse events leading to chemo-immune checkpoint inhibitor-therapy discontinuation up to six months after enrolment.
Eligible patients will be registered in the study database and randomized in 1:2 ratio to either the standard group (systemic anti-tumor therapy with or without ICI with endoscopic biliary stenting) or the experimental bRFA group (systemic anti-tumor therapy with or without ICI with endoscopic biliary stenting + bRFA).
Systemic anti-tumor therapy with or without ICI with endoscopic biliary stenting are standard of care applied commonly in both the control and the experimental group:
Endoscopic retrograde cholangiography (ERC) procedure stenting are applied at baseline and as clinically indicated. E.g., CICI cycles (Gemcitabin d1 \& d8, Cisplatin d1 \& d8, Durvalumab d1) are administered repeating every 21 days for a total of 8 cycles.
bRFA will be applied only to the experimental group, it is standardized as for generator settings and protocol adapting to tumor morphology using the probe at baseline, 6 and 12 weeks after study start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Gemcitabin, Cisplatin and Durvalumab, Procedure: Endoscopic Retrograde Cholangio-Pancreatography with stentingStandard of care consisting of chemotherapy + durvalumab + endoscopic stenting |
| Biliary radiofrequency ablation | Experimental | Drug: Gemcitabin, Cisplatin and Durvalumab, Procedure: Biliary Radiofrequency Ablation, Procedure: Endoscopic Retrograde Cholangio-Pancreatography with stentingStandard of care consisting of chemotherapy + durvalumab + endoscopic stenting plus intraductal radiofrequency ablation (bRFA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Male or female ≥18 years old.
- Histologically or cytologically confirmed diagnosis of previously untreated and unresectable*, locally advanced and/or metastatic extrahepatic biliary tract cholangiocarcinoma with obstructive jaundice (increased serum level of total bilirubin).
- ECOG performance status 0 to 2.
- Adequate bone marrow function: Neutrophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L.
- Adequate renal function in case of cisplatin administration: Estimated Glomerular Filtration Rate (eGFR) ≥60mL/min/1.73m2.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gemcitabin, Cisplatin and DurvalumabCICI (Gemcitabin d1 \& d8 Cisplatin d1 \& d8, Durvalumab d1) are administered repeating every 21 days for a total of 8 cycles. | Drug | Biliary radiofrequency ablation, Control arm |
| Biliary Radiofrequency AblationBiliary Radiofrequency Ablation is applied at baseline, 6 and 12 weeks | Procedure or surgery | Biliary radiofrequency ablation |
| Endoscopic Retrograde Cholangio-Pancreatography with stentingERCP with stenting are applied at baseline and as clinically indicated | Procedure or surgery | Biliary radiofrequency ablation, Control arm |
Primary outcome
Any grade 3 or 4 adverse events (AE) leading to systemic anti-tumor therapy with or without ICI discontinuation up to six months after randomization.
Time frame: 6 months
AEs will be assessed according to US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5). Treatment discontinuation is defined as deferral of administration by at least four weeks or a definite stop of all systemic anti-tumor therapy with or without ICI agents.
11 secondary outcomes
Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions
Time frame: 6 months
Progression-free survival: The time until either progression of the underlying disease or death, whichever occurs first, assessed from the time of up to 6 months after randomization.
Time frame: 6 months
Death from any cause at the follow-up at 6 months after randomization (overall survival).
Time frame: 6 months
Disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle and at 3 and 6 months after the start of CICI treatment.
Time frame: 6 months
Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C30
Time frame: 6 months
Stent patency at month 3 visit and at 6 months after the start of CICI treatment.
Time frame: 6 months
Number of courses of CICI applied
Time frame: 6 months
Total dose of CICI applied
Time frame: 6 months
Number of patients with any grade 3 or 4 Adverse Events (AE) leading to discontinuation or non-initiation of CICI up to six months after randomization.
Time frame: 6 months
Number of patients not starting CICI within 4 weeks after randomization.
Time frame: 6 months
Time from randomization to CICI start.
Time frame: 6 months
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 26 May 2026.
- Background: PubMed 37075781Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.
- Background: PubMed 37452505Rimini M, Fornaro L, Lonardi S, Niger M, Lavacchi D, Pressiani T, Lucchetti J, Giordano G, Pretta A, Tamburini E, Pirrone C, Rapposelli IG, Diana A, Martinelli E, Garajova I, Simionato F, Schirripa M, Formica V, Vivaldi C, Caliman E, Rizzato MD, Zanuso V, Nichetti F, Angotti L, Landriscina M, Scartozzi M, Ramundo M, Pastorino A, Daniele B, Cornara N, Persano M, Gusmaroli E, Cerantola R, Salani F, Ratti F, Aldrighetti L, Cascinu S, Rimassa L, Antonuzzo L, Casadei-Gardini A. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real-world data. Liver Int. 2023 Aug;43(8):1803-1812. doi: 10.1111/liv.15641.
- Derived from this study: PubMed 41816011Pfister T, Chan SCW, Trelle S, Butikofer S, Winterhalder R, Koessler T, Schlag C, Fritsch R, Frossard JL, Moser A, Berger MD, Wiest R. Ablatio-bilica: safety of biliary intraductal radiofrequency ablation in patients with unresectable extrahepatic biliary tract cancer undergoing systemic anti-tumor therapy: a phase II, multi-center, randomized, and controlled study. Front Oncol. 2026 Feb 24;15:1576401. doi: 10.3389/fonc.2025.1576401. eCollection 2025.
- Individual participant dataSharing planned: No. This will be planned only at study completion
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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.
Prof. Dr. med. Reiner Wiest principal investigator
Inselspital Bern University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabin, Cisplatin and Durvalumab, Biliary Radiofrequency Ablation and Endoscopic Retrograde Cholangio-Pancreatography with stenting in people with Bile Duct Cancer, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
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 40 inclusion and 0 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Prof. Dr. med. Reiner Wiest (+41 31 632 59 41, reiner.wiest@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any grade 3 or 4 adverse events (AE) leading to systemic anti-tumor therapy with or without ICI discontinuation up to six months after randomization. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274879, which also lists 3 linked publications.
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 26 May 2026.