Patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine treatment.
Conditions
Interventions
Trade Name: Lonsurf
Product Name: TAS-102
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Trifluridin
CAS Number: 70-00-8
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Heinrich-Heine-University Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) prior to performing any protocol-related procedures, including screening evaluations 2. Age = 18 years at time of study entry 3. Histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma 4. Measurable or assessable disease according to RECIST 1.1 5. Documented disease progression after prior gemcitabine or gemcitabine containing therapy. Examples of permitted therapies include, but are not limited to: a) Single agent gemcitabine); b) Any gemcitabine-based regimen, with or without maintenance gemcitabine 6. ECOG performance status 0-1 7. Ability to take medications orally 8. Adequate blood count, liver-enzymes, and renal function: - ANC > 1,500 cells/µL without the use of hematopoietic growth factors; and Platelet count = 100 x 109/L (>100,000 per mm3) and Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL) - Serum total bilirubin = 1.5x upper normal limit (ULN) (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values): - Albumin levels = 3.0 g/dL - Patients not receiving therapeutic anticoagulation must have an INR=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1. Age grade 1 6. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results 7. Known hypersensitivity to Trifluridine/Tipiracil or CPT-11 or their components 8. Medication that is known to interfere with any of the agents applied in the trial 9. Pregnancy or lactating female 10. Prior partial or total gastrectomy 11. Previous radio- or radiochemotherapy, previous transarterial chemoembolisation (TACE), radiofrequencyablation (RFA) or selective intraarterial radiotherapy (SIRT) within 3 months prior to inclusion (except radiation for bone metastases) 12. Patients who might be dependent on the sponsor, site or the investigator 13. Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG. 14. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG]. 15. Use of other investigational treatment within 5 half-lives of enrollment is prohibited.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the efficacy of a combination therapy of Trifluridine/Tipiracil and Irinotecan in patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine treatment.;Secondary Objective: Translational research program: 1)cfDNA exome sequencing 2)Circulating miRNAs and lncRNAs 3)Concentrations of inflammatory cytokines 4)Gut microbiome analysis;Primary end point(s): Median progression free survival (PFS) assessed by the local investigator ;Timepoint(s) of evaluation of this end point: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival rate @ 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion by intention to treat analysis - Median overall survival - Proportion of patients with an objective response according to RECIST 1.1 - Safety (type, grade and frequency of AEs/SAEs) - Analysis of quality of life (EORTC QLQ-30 and the EQ-5D-5Lquestionnaires) Response and progression will be assessed by the local investigator;Timepoint(s) of evaluation of this end point: At 4 months resp. at the end of study | — |
Countries
Germany
Contacts
Public ContactGastroenterology, Hepatology & Dia
University Hospital Center Düsseldorf
Outcome results
None listed