Trifluridine, Tipiracil hydrochloride for Cholangiocarcinoma | Gallbladder carcinoma

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma"}
• {"criterion_text":"- Measurable or assessable disease according to RECIST 1.1"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- CNS metastases"}
• {"criterion_text":"- Clinically significant gastrointestinal disorders including bleeding, inflammation, occlusion, or diarrhea > grade 1"}

Primary endpoints

• {"endpoint_text":"- Median progression free survival (PFS) assessed by the local investigator at each site (time from first administration of chemotherapy to the date of radiological or clinical tumor progression or death of any cause whichever comes first).","definition_or_measurement_approach":"Assessed by the local investigator at each site; time from first administration of chemotherapy to radiological or clinical tumor progression or death from any cause, whichever occurs first."}

Secondary endpoints

• {"endpoint_text":"- Progression-free survival rate at 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion by intention to treat analysis","definition_or_measurement_approach":"Proportion of patients without disease progression 4 months after inclusion (intention-to-treat analysis)."}
• {"endpoint_text":"- Median overall survival (time interval from first administration of chemotherapy to date of death from any cause)","definition_or_measurement_approach":"Time from first administration of chemotherapy to death from any cause; median OS will be calculated."}
• {"endpoint_text":"- Proportion of patients with an objective response according to RECIST 1.1","definition_or_measurement_approach":"Objective response per RECIST 1.1 criteria as assessed (local investigator)."}
• {"endpoint_text":"- Type, frequency and severity of adverse events according to NCI CTCAE version 5.0 specifying seriousness and expectedness (AE, SAE, SUSAR)","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0, with specification of seriousness and expectedness (AE, SAE, SUSAR)."}
• {"endpoint_text":"- Health related QoL according to EORTC QLQ C30 and the EQ-5D-5L","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30 and EQ-5D-5L questionnaires."}

Germany

Earliest CTIS Part Ii Submission Date

17-07-2025

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

116

Number Of Sites

7

Number Of Participants

38

Primary sponsor

Full Name

Heinrich-Heine-Universitaet Duesseldorf

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Acnos Pharma GmbH","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"","full_name":"SERVIER Deutschland GmbH","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Servier Affaires Médicales","duties_or_roles":"Monetary support","organisation_type":""}