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Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carrelizumab
Solfantinib
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: Advanced inability to root was pathologically confirmed Patients with curatively resected or metastatic bile duct epithelial cell carcinoma; had previously received systemic antitumor therapy with a chemotherapy regimen (including gemcitabine) Age ≥18 and under 75 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 allergies to carrilizumab or solfantinib machine components Patients with obstructive jaundice who could not reach the upper limit of TBIL≤2.5 times of normal value 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, cervical cancer in situ) 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 take appropriate contraceptive measures during the course of the 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

    In this study, carrilizumab combined with sovantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials.The specific treatment regimen was carrilizumab 200mg Q3W d1; Sofantinib: 300mg,Take orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to treatment regimens.The efficacy was evaluated every 2 cycles.

    Outcomes

    Primary Outcome Measures

    PFS
    Progression Free Survival

    Secondary Outcome Measures

    ORR
    Objective Response Rate
    OS
    Overall Survival
    DCR
    Disease control rate Disease control rate Disease control rate

    Full Information

    First Posted
    December 21, 2022
    Last Updated
    January 16, 2023
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05697237
    Brief Title
    Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
    Official Title
    Exploratory Clinical Study of Carlizumab Plus Sovantinib in 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 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (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
    The incidence of cholangiocarcinoma is high, the radical resection rate is low, the postoperative recurrence is easy, the prognosis is poor.Gemcitabine combined with cisplatin (GC) is the standard first-line treatment for patients with advanced biliary carcinoma, and up to now there is no standard second-line treatment Commend.Carrilizumab was highly effective in previous studies,Its combined GEMOX protocol has been published in the "Guidelines for the Diagnosis and Treatment of Gallbladder Cancer (2019 Edition)" and the "China Clinical Oncology" The Society's (CSCO) Guidelines for the Diagnosis and Treatment of Biliary alignancies 2020 is recommended for the first-line treatment of advanced biliary cancers.Solfantinib is targeted at VEGFR1, 2, 3, FGFR1And CSF1R highly selective small molecule targeted therapy drugs. Data from a preliminary phase 2 clinical trial observed sofantinib therapy Survival benefits of cholangiocarcinoma patients in China.
    Detailed Description
    In this study, carrilizumab combined with suvantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials. The study plan enlists 60 patients with unresectable or recurrent disease confirmed by histopathology or cytology Or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, distal cholangiocarcinoma). Past acceptance of standard containing Systematic internal medicine anti-tumor therapy with gemcitabine regimen met the inclusion criteria of this study, and carrilizumab combined with cord was given Vantinib oral therapy. The specific treatment regimen was carrilizumab 200mg Q3W d1; Solventinib: 300mg, Orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to the treatment regimen The efficacy was evaluated every 2 cycles. The main evaluation of carrilizumab combined with suvantinib in second-line treatment was advanced or Progression-free survival (PFS) in patients with metastatic cholangiocarcinoma.

    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
    In this study, carrilizumab combined with sovantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials.The specific treatment regimen was carrilizumab 200mg Q3W d1; Sofantinib: 300mg,Take orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to treatment regimens.The efficacy was evaluated every 2 cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Carrelizumab
    Intervention Description
    Carrelizumab 200mg/3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Solfantinib
    Intervention Description
    Solfantinib 300mg/d
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    Progression Free Survival
    Time Frame
    6months
    Secondary Outcome Measure Information:
    Title
    ORR
    Description
    Objective Response Rate
    Time Frame
    6months
    Title
    OS
    Description
    Overall Survival
    Time Frame
    12months
    Title
    DCR
    Description
    Disease control rate Disease control rate Disease control rate
    Time Frame
    6months

    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: Advanced inability to root was pathologically confirmed Patients with curatively resected or metastatic bile duct epithelial cell carcinoma; had previously received systemic antitumor therapy with a chemotherapy regimen (including gemcitabine) Age ≥18 and under 75 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 allergies to carrilizumab or solfantinib machine components Patients with obstructive jaundice who could not reach the upper limit of TBIL≤2.5 times of normal value 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, cervical cancer in situ) 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 take appropriate contraceptive measures during the course of the 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
    1159950306@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    rui qu
    Phone
    +18681943306
    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

    Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

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