Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma

Sponsor
Heinrich-Heine University, Duesseldorf
Study ID
NCT04059562
Phase
PHASE2
Status
Completed

Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Combination of Lonsurf® and Irinotecan — COMBINATION_PRODUCT
    Trifluridine/Tipiracil (Lonsurf®) and Irinotecan * Trifluridine/Tipiracil will be administered at a dose of 25 mg/m2 / dose twice daily on days 1-5 followed by a 9-days recovery period from day 6 trough day 14 of each 14-days treatment cycle. * Irinotecan will be administered at the same time as Trifluridine/Tipiracil (Lonsurf®) on day 1 of each cycle at a dose of 180 mg/m2 / dose.

Study Details

This is a prospective, single arm, open label, non-randomized, exploratory, multi-centre pilot study with median progression free survival as primary outcome. In total 28 patients (including 3 calculated drop outs and invalid cases) with advanced cholangiocellular carcinoma after failure of a gemcitabine based first-line therapy will be enrolled at 5 centres. 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. The study will be accompanied by a translational research program: Before treatment and after each radiological tumor assessment (Q6W) blood and stool will be collected and extensive panels of biomarkers will be accessed.

Key Dates

Start date
Oct 28, 2021
Status verified
Mar 2024
Primary completion
Jan 8, 2024
Completion
Jan 8, 2024

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Combination of Lonsurf® and Irinotecan

Primary Outcome Measure

Median progression free survival (PFS) [ Time Frame: through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up) ]

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