Advanced or Metastatic Cholangiocarcinoma

Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Study ID
NCT05653817
Status
Unknown

Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Carrilizumab — DRUG
    Carrilizumab 200mg Q3W d1
  • Albumin-bound paclitaxel — DRUG
    Albumin-bound paclitaxel 125 mg/m2 d1,8
  • Apatinib — DRUG
    Apatinib mesylate tablets for treatment: 250mg

Study Details

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.

Key Dates

Start date
Jan 31, 2023
Status verified
Dec 2022
Primary completion
Jan 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced or metastatic cholangiocarcinoma
    A multicenter clinical study of carralizumab combined with albumin paclitaxel and apatinib mesylate in the second-line treatment of advanced or metastatic cholangiocarcinoma.Albumin-bound paclitaxel 125 mg/m2 d1,8; Carrilizumab 200mg Q3W d1; Apatinib mesylate tablet treatment: 250mg orally, once a day, continuous administration. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen.

Primary Outcome Measure

PFS [ Time Frame: 24month ]

Central Contacts

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