PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrah… (NCT04099888) | Clinical Trial Compass
TerminatedPhase 2
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
Stopped: Recent results from a Phase 3 study are expected to change the standard of care for patients with inoperable CCA, rendering the RELEASE study challenging to complete and potentially inadequate for NDA approval.
United States, Belgium, Denmark41 participantsStarted 2019-05-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — can you find out why it was stopped early, and what that means for whether the PCI plus gemcitabine combination approach is still considered worth exploring?
2Since this was a Phase 2 trial studying progression-free survival, does that mean we still don't have strong evidence on whether adding PCI treatment to chemotherapy actually helps people live longer with extrahepatic bile duct cancer?
3Given that this trial is no longer recruiting, are there any other active trials studying PCI or similar approaches for my type of bile duct cancer that might be worth looking into?
4How does the combination approach this trial was testing — PCI plus gemcitabine and chemotherapy — compare to what you would recommend as standard treatment for my situation right now?
5Because this trial was terminated, is there any published data from the patients who did participate that could help us understand whether this treatment direction showed any early signs of benefit or harm?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Estimated life expectancy of at least 12 weeks.
Exclusion criteria
. 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.