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Efficacy and safety of trifluridin/tipiracil in combination with nanoliposomal irinotecan as a second line therapy in patients with cholangiocarcinoma
EU CTIS ID: 2024-517330-18-00
What this study is testing
To examine the efficacy of a combination therapy of trifluridine/tipiracil and nanoliposomal irinotecan in patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine-based treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma
- Measurable or assessable disease according to RECIST 1.1
- Documented disease progression after prior gemcitabine or gemcitabine containing therapy or intolerance to such a treatment. Examples of permitted therapies include, but are not limited to: a) Single agent gemcitabine); b) Any gemcitabine-based regimen, with or without maintenance gemcitabine
- Patients with available molecular tumor profiling may only be included if they are not eligible for approved targeted therapies or if they reject approved targeted therapies. Eligibility for such therapies is determined by the local interdisciplinary tumor board or molecular tumor board, based on the results of molecular testing, clinical criteria, and the patient’s preference.
You likely can't join if
- CNS metastases
- Clinically significant gastrointestinal disorders including bleeding, inflammation, occlusion, or diarrhea > grade 1
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.