PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer

Stopped early · Phase 2

Conditions studied: Cholangiocarcinoma

In brief

This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

Key facts

Study ID

NCT04099888

Run by

PCI Biotech AS

People needed

41

Starts

2019-05-23

Expected to finish

2022-05-06

Last updated by the study team

2023-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each patient must provide signed and witnessed written informed consent and agree to comply with study protocol requirements.
• Histopathologically/cytologically verified adenocarcinoma consistent with cholangiocarcinoma (CCA). Must have biliary lesion causing bile obstruction that requires stenting and is accessible for PCI light treatment (ie, extrahepatic CCA [perihilar or distal] only).
• CCA must be considered inoperable with respect to radical resection.
• At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation.
• If metastatic, metastases must be limited tissues other than bone or the central nervous system.
• Must have adequate biliary drainage (at least 50% of the liver volume or at least 2 sectors) with no evidence of active uncontrolled infection (patients on antibiotics are eligible).
• Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Estimated life expectancy of at least 12 weeks.

You may not qualify if…

• Patients who have previously received any anti-tumor (either local or systemic) treatment for CCA, except for previous treatment of up to 2 cycles of gemcitabine/cisplatin.
• Patients with severe visceral disease other than CCA.
• A history of frequently recurring septic biliary events.
• Patients with porphyria or hypersensitivity to porphyrins.
• Patients with a second primary cancer with a disease-free interval of <5 years. A second primary cancer that has been treated with intent to cure may be allowed after consultation with the study Medical Monitor. Adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study) are allowed.
• Patients not able to undergo contrast-enhanced CT or MRI.
• Patients currently participating in any other interventional clinical trial.
• Planned surgery, endoscopic examination or dental treatment in the first 30 days after PCI treatment.
• Co-existing ophthalmic disease likely to require slit-lamp examination within the first 90 days after PCI treatment.
• Clinically significant and uncontrolled cardiac disease except for extra systoles or minor conduction abnormalities and controlled and well-treated chronic atrial fibrillation.
• Known allergy or sensitivity to photosensitisers (active substance and/or any of the excipients); or chronic use of other photosensitising therapies; treatment with amiodarone during the last 12 months.
• Known hypersensitivity to or contraindication to the use of gemcitabine (active substance and/or any of the excipients).
• Known hypersensitivity to or contraindication to the use of cisplatin (active substance and/or any of the excipients).
• Patients with ataxia telangiectasia.
• Upon the Investigator's discretion, evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned PCI treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
• Patients planning to have or who have recently had vaccination with a live vaccine.
• Patients concurrently receiving treatment with phenytoin.
• Male patients unwilling to use highly effective contraception or female patients of childbearing potential unwilling to use highly effective form of contraception. Patients must continue the use of contraception during PCI treatment and subsequent chemotherapy for at least 6 months thereafter.
• Women who are breastfeeding or who have a positive pregnancy test at baseline.
• Patients with inadequate bone marrow function (absolute neutrophil count <1.5 x 10\^9/L; platelet count <100 x 10\^9/L; haemoglobin <6 mmol/L [transfusion allowed]).
• Inadequate liver function despite satisfactory drainage (serum bilirubin persisting at >5 x upper limit of normal for the institution; aspartate aminotransferase or alanine aminotransferase >3.0 x upper limit of normal or >5 x upper limit of normal if liver metastases are present; alkaline phosphatase levels >5.0 x upper limit of normal).
• Inadequate renal function, as determined by local practice for patients on fractionated platinum-based chemotherapy. Patients with creatinine clearance <45 mL/min (in France: <60 mL/min) must not be included.
• Other protocol-defined criteria may apply.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Emory University Hospital, 1365C Clifton Road NE — Atlanta, Georgia, United States
• University of Chicago Medical Center, 5841 South Maryland Avenue — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• The Mayo Clinic Hospital - Saint Mary's Campus, 1216 Second Street Southwest — Rochester, Minnesota, United States
• Baylor College of Medicine — Houston, Texas, United States
• UZ Gent — Ghent, Oost-Vlaanderen, Belgium
• UZ Leuven — Leuven, Belgium
• Odense Universitetshospital — Odense, Denmark
• Tampereen yliopistollinen sairaala, Syöpätautien klinikka — Tampere, Finland
• Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon — Grenoble, Cedex 09, France
• CHU Angers — Angers, Cedex 9, France
• CHU Dupuytren, 2 Avenue Martin Luther King — Limoges, France
• Institut Gustave Roussy, Département de gastro-entérologie — Villejuif, France
• Klinikum rechts der Isar der Technischen Universität München — München, Bavaria, Germany
• Universitätsklinikum Frankfurt — Frankfurt am Main, Hesse, Germany
• Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany
• Universitätsklinikum Bonn — Bonn, Germany
• Universitätsklinikum Hamburg Eppendorf, I. Medizinische Klinik und Poliklinik (Gastroenterologie mit Sektionen Infektiologie und Tropenmediz) — Hamburg, Germany
• Klinikum Landshut — Landshut, Germany
• LAKUMED Kliniken — Landshut, Germany
• Universität Leipzig KöR — Leipzig, Germany
• Klinikum Mannheim Universitätsklinikum gGmbH — Mannheim, Germany
• Klinikum der Ludwig-Maximilians-Universität MünchenKlinik — München, Germany
• Klinikum Nürnberg Nord, Medizinische Klinik 6 - (Schwerpunkte Gastroenterologie, Hepatologie, Endokrinologie) — Nuremberg, Germany

Full record on ClinicalTrials.gov

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