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Advanced or Metastatic Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carrilizumab
Albumin-bound paclitaxel
Apatinib
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma; Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel; Age ≥18 years old and under 75 years old; Predicted survival ≥3 months; ECOG score 0-1; Child-Pugh score<8 There was at least one measurable tumor lesion with a long diameter ≥10 mm and a short diameter ≥15 mm on spiral CT. For general CT or physical examination, the maximum diameter must be ≥20mm; The results of liver and kidney function and blood routine examination within 1 week before enrollment were consistent with the following conditions, ANC≥1.5×10^9/L,PLT≥80×10^9/L,HGB≥80g/L,Cr≤1.5×ULN,TBIL≤2.5×ULN,ALP≤2.5×ULN,AST≤2.5×ULN,ALT≤2.5×ULN Patients participate voluntarily and sign informed consent forms Exclusion Criteria: Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel; Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention; Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks; Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency; History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix); Interstitial pneumonia or pulmonary fibrosis; Uncontrollable pleural effusion or ascites; Severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months); Pregnant or lactating mothers who refused to use appropriate contraceptive methods during the course of this study; The researchers determined that the patients were not suitable for this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Advanced or metastatic cholangiocarcinoma

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    PFS
    Progression-free survival

    Secondary Outcome Measures

    OS
    Overall survival

    Full Information

    First Posted
    December 9, 2022
    Last Updated
    December 9, 2022
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05653817
    Brief Title
    Advanced or Metastatic Cholangiocarcinoma
    Official Title
    A Multicenter Clinical Study of Carralizumab Combined With Albumin Paclitaxel and Apatinib Mesylate in the Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 31, 2023 (Anticipated)
    Primary Completion Date
    January 31, 2025 (Anticipated)
    Study Completion Date
    January 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    Detailed Description
    Cholangiocarcinoma (CCA) is a cancer that easily invades adjacent structures. Vascular endothelial growth factor (VEGF) and VEGF receptor 2 (VEGFR2) are increased in most types of cancer and inhibit tumor progression by blocking VEGF/VEGFR2 [16]. Apatinib is a highly selective VEGFR2 antagonist that inhibits apoptosis and growth of CCA cells. Apatinib is also a derivative of PTK787, and its targets include VEGFR-1, VEGFR-2, PDGFR, c-kit, c-Src, etc. The activity of Apatinib against VEGFR-2 is 137 times that of PTK787, the IC50 is only 1nmol/L, and it can strongly inhibit tumor angiogenesis. At the same time, it can also inhibit the downstream signal transduction mediated by KDR and inhibit tumor growth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholangiocarcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Advanced or metastatic cholangiocarcinoma
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Carrilizumab
    Intervention Description
    Carrilizumab 200mg Q3W d1
    Intervention Type
    Drug
    Intervention Name(s)
    Albumin-bound paclitaxel
    Intervention Description
    Albumin-bound paclitaxel 125 mg/m2 d1,8
    Intervention Type
    Drug
    Intervention Name(s)
    Apatinib
    Intervention Description
    Apatinib mesylate tablets for treatment: 250mg
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    Progression-free survival
    Time Frame
    24month
    Secondary Outcome Measure Information:
    Title
    OS
    Description
    Overall survival
    Time Frame
    24month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma; Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel; Age ≥18 years old and under 75 years old; Predicted survival ≥3 months; ECOG score 0-1; Child-Pugh score<8 There was at least one measurable tumor lesion with a long diameter ≥10 mm and a short diameter ≥15 mm on spiral CT. For general CT or physical examination, the maximum diameter must be ≥20mm; The results of liver and kidney function and blood routine examination within 1 week before enrollment were consistent with the following conditions, ANC≥1.5×10^9/L,PLT≥80×10^9/L,HGB≥80g/L,Cr≤1.5×ULN,TBIL≤2.5×ULN,ALP≤2.5×ULN,AST≤2.5×ULN,ALT≤2.5×ULN Patients participate voluntarily and sign informed consent forms Exclusion Criteria: Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel; Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention; Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks; Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency; History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix); Interstitial pneumonia or pulmonary fibrosis; Uncontrollable pleural effusion or ascites; Severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months); Pregnant or lactating mothers who refused to use appropriate contraceptive methods during the course of this study; The researchers determined that the patients were not suitable for this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yangwei fan, phd
    Phone
    +8615029078171
    Email
    1289271841@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    enxiao li, PHD
    Organizational Affiliation
    First hospital of Xi'an Jiaotong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Advanced or Metastatic Cholangiocarcinoma

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