drugset / Trial / NCT05653817

Advanced or Metastatic Cholangiocarcinoma

NCT05653817

NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open, multicenter trial of carralizumab in combination with albumin paclitaxel and apatinib mesylate for the second-line treatment of patients with advanced or metastatic cholangiocarcinoma. The study enlists patients with histopathologically or cytologically confirmed unresectable, recurrent, or metastatic cholangiocarcinoma (including intrahepatic, extrahepatic, and distal cholangiocarcinoma). Previously, she had received systematic internal medicine anti-tumor therapy with gemcitabine regimen as standard, which met the inclusion criteria of this study. She was given oral therapy with albumin binding paclitaxel combined with carrilizumab and apatinib mesylate. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen. To evaluate progression-free survival (PFS) in second-line therapy with carrilizumab in combination with albumin paclitaxel and apatinib mesylate in patients with advanced or metastatic cholangiocarcinoma.

Timeline

Start
2023-01-31
Primary completion
2025-01-31
Completion
2026-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carrilizumab Monoclonal antibody 200 mg
Subject Paclitaxel Small molecule 125 mg/m2
Subject Rivoceranib Small molecule 250 mg Oral

Indications