A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Ch… (NCT01900158) | Clinical Trial Compass
CompletedPhase 1
A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas
France, Germany, Norway24 participantsStarted 2013-05
Plain-language summary
This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy will be assessed in patients with advanced inoperable cholangiocarcinomas.
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
. Histopathologically/cytologically (C5) verified adenocarcinoma consistent with cholangiocarcinoma
. Cholangiocarcinoma that:
. Adequate biliary drainage (either at least 50% of the liver volume, or at least two sectors), with no evidence of active uncontrolled infection (patients on antibiotics are eligible).
. Age ≥ 18 years.
. Performance status ECOG ≤ 1.
. Estimated life expectancy of at least 12 weeks.
. Written informed consent.
Exclusion criteria
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.
1Since this trial is Phase I and focused primarily on finding safe doses of PCI-enhanced gemcitabine rather than proving it works, what does that mean for understanding the actual benefit versus risk for someone with my diagnosis?
2The trial measured 'dose-limiting toxicities' — can you explain what kinds of side effects were being watched for, and what was found in terms of safety now that the study is completed?
3PCI, or photochemical internalization, is a fairly specialized technique — how widely available is it, and would my current treatment center even be able to offer something like this if it turned out to be relevant for me?
4Given that this trial has already completed, are the results published or available anywhere, and do they suggest this approach might move forward into a larger Phase II or Phase III study that I could potentially be eligible for?
5Before considering an experimental approach like this, should I first explore whether standard chemotherapy options for cholangiocarcinoma have been fully exhausted, or is there a reason this kind of trial might be worth discussing earlier in my treatment?
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.
What they're measuring
1
Dose-limiting toxicities (DLT) and the safety profile
Timeframe: up to 6 months
2
Schedule-limiting toxicities (SLTs) and the safety profile
. Any prior anti-cancer (either local or systemic) treatment for cholangiocarcinoma.
. Patients with extra-hepatic metastatic cholangiocarcinoma.
. Patients with a severe visceral disease other than cholangiocarcinoma.
. Patients with primary sclerosing cholangitis.
. Patients with porphyria or hypersensibility to porphyrins.
. Patients with an active second primary cancer, with exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix. An active second primary cancer is defined as one with a disease-free interval of \< 5 years before registration/randomization.
. Inability to undergo CT or MRI.
. Current participation in any other interventional clinical trial.