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Clinical trial

A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy

NCT07328919 is registered in ClinicalTrials.gov with TransThera Sciences (Nanjing), Inc. as lead sponsor.

NCT NCT07328919
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy
Lead sponsor
TransThera Sciences (Nanjing), Inc.
Phase
Phase 3
Overall status
Not yet recruiting
Start date
January 31, 2026
Completion date
December 31, 2030
Enrollment
138 (estimated)
Sites
20

Conditions

As the registry lists them; a condition with its own page is linked.

advanced cholangiocarcinoma, intrahepatic cholangiocarcinoma (icc)