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Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC (Modified)

Primary Purpose

Biliary Tract Neoplasms

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Total Neoadjuvant Treatment
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Neoplasms

Eligibility Criteria

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

Inclusion Criteria: Male or female Age ≥ 18 years，≤ 75 years Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically Ability to provide written informed consent prior to participation in any study-related procedure Eastern Cooperative Oncology Group (ECOG) performance status 0-1 At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1). Adequate organ function Exclusion Criteria: Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma Known history of a serious allergy to any monoclonal antibody Any active malignancy prior to the start of treatment Active or history of autoimmune disease Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation Pregnant or lactating women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental

    Arm Description

    NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation

    Outcomes

    Primary Outcome Measures

    Objective response rate (ORR)
    ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1

    Secondary Outcome Measures

    overall survival (OS)
    Overall survival

    Full Information

    First Posted
    September 7, 2023
    Last Updated
    September 7, 2023
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06037655
    Brief Title
    Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
    Acronym
    Modified
    Official Title
    Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.
    Detailed Description
    After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Tract Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation
    Intervention Type
    Drug
    Intervention Name(s)
    Total Neoadjuvant Treatment
    Intervention Description
    Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously
    Primary Outcome Measure Information:
    Title
    Objective response rate (ORR)
    Description
    ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
    Time Frame
    18 weeks
    Secondary Outcome Measure Information:
    Title
    overall survival (OS)
    Description
    Overall survival
    Time Frame
    2 years
    Other Pre-specified Outcome Measures:
    Title
    Progression free survival (PFS)
    Description
    PFS is defined as time interval from recruitment to tumor progression or censoring
    Time Frame
    2 years
    Title
    Pathological Complete Response Rate (pCR)
    Description
    pathological complete response rate
    Time Frame
    18 weeks
    Title
    Major Pathological Response Rate (MPR)
    Description
    MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)
    Time Frame
    18 weeks

    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: Male or female Age ≥ 18 years，≤ 75 years Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically Ability to provide written informed consent prior to participation in any study-related procedure Eastern Cooperative Oncology Group (ECOG) performance status 0-1 At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1). Adequate organ function Exclusion Criteria: Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma Known history of a serious allergy to any monoclonal antibody Any active malignancy prior to the start of treatment Active or history of autoimmune disease Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation Pregnant or lactating women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiangcheng Li
    Phone
    18951999088
    Email
    drlixc@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaofeng Chen
    Phone
    13585172066
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiangcheng Li
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Xiaofeng Chen
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC

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