A global, multicenter, randomized, controlled Phase III study to evaluate the efficacy and safety of oral tinengotinib compared with the physician’s choice in patients with refractory or recurrent cholangiocarcinoma with altered fibroblast growth factor receptor (FGFR), chemotherapy, and FGFR inhibitors.
Principal Investigator
Dott.ssa Virginia Quarà
Contact Information for Access
Phase
FASE III
Status
ATTIVO
Objective of the study
To evaluate the safety and tolerability of tinengotinib at doses of 8 mg once daily (QD) and 10 mg once daily (QD) in patients with FGFR-altered cholangiocarcinoma (CCA) who are refractory or have relapsed following chemotherapy and treatment with FGFR inhibitors.
To evaluate the efficacy of tinengotinib at the dose selected for Part B, based on progression-free survival (PFS) as assessed by independent central blinded review (BICR), compared with physician’s choice of therapy, in patients with CCA with FGFR alterations, refractory or recurrent after chemotherapy and treatment with FGFR inhibitors.
Cholangiocarcinoma
ClinicalTrials.gov ID NCT05948475
Sponsor: TransThera Sciences (Nanjing), Inc.
Pathologies
Gastrointestinal tumor (GI tumor)
Medication
Tinengotinib, Oxaliplatin, Leucovorin, and Irinotecan.
Who is eligible to participate in the study?
Adult patients.
Patients who have received prior treatment.
View the full study Back to search page