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Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Primary Purpose

PFS

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Decitabine Injection
tirelizumab
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PFS

Eligibility Criteria

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

Inclusion Criteria: Subjects voluntarily participate and sign written informed consent; Age ≥18 years; Confirmed by histopathology and/or cytology as esophageal squamous cell carcinoma; At least one measurable lesion according to AJCC 8th staging and RECIST 1.1 solid tumor evaluation criteria. Those who have received immunocheckpoint inhibitors combined with chemotherapy (e.g., paclitaxel + cisplatin) in the first line, and the disease has not progressed; Good functioning of major organs, no serious uncontrolled hypertension, diabetes and heart disease, that is, the relevant indicators within 14 days before treatment meet the following requirements: ANC≥1.2×109/L and lymphocyte count ≥0.5×109/L without the support of granulocyte colony stimulating factor; Without blood transfusion, patients with platelet count ≥100×109/L and hemoglobin ≥90g/L can meet the criteria through blood transfusion; AST, ALT and ALP≤2.5× upper limit of normal (ULN), total bile red ≤1.5×ULN, except the following conditions: for known Gilbert patients: total bilirubin ≤3×ULN, creatinine ≤1.5×ULN, albumin ≥25g/L; For patients not receiving anticoagulant therapy: INR and aPTT≤1.5×ULN. estimated survival ≥3 months; Score of ECOG physical strength: 0~1; The ability of patients to follow the study protocol according to the judgment of the investigator. Exclusion Criteria: Previous immunotherapy; no measurable lesions; There are small cell carcinoma, adenocarcinoma or mixed carcinoma components in the histology; Complete esophageal obstruction; Any NCI CTCAE≥ Grade 2 toxicity that has not recovered after previous chemotherapy; High risk of esophageal fistula was found through clinical evaluation or imaging examination, such as history of esophageal fistula or related symptoms, or primary tumor infiltration into large blood vessels or trachea; had positive detection for EB virus (EBV) capsid antigen IgM during screening (PCR method); If a patient requires analgesic treatment, the treatment regimen used at the time of enrollment must be stable; The men who have HIV positive results at the time of screening; people who test positive for hepatitis C virus (HCV) during sieving; HBV positive screening, and cccDNA≥500 IU/mL; Any of the following diseases in the 12 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident; Pregnant or lactating women or fertile but did not take contraceptive measures; suffer any other serious physical or mental problem of an acute or chronic nature; judging by the researchers, that doesn't fit to participate in the study. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    low-dose decitabine combined with tirelizumab

    tirelizumab

    Arm Description

    Injection site citabine, 10 mg/ bottle, 10 mg/d, Q3W, D1-D5 intravenous infusion; Tirelizumab injection 200mg D5 intravenous infusion.

    Tirelizumab injection, 10ml: 100mg/1 bottle, 200mg, Q3W, D1 IV infusion.

    Outcomes

    Primary Outcome Measures

    PFS
    Progression-Free Survival

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2022
    Last Updated
    November 24, 2022
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05638984
    Brief Title
    Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
    Official Title
    A Low Dose Decitabine Combined With Tirelizumab Prospective Phase II Clinical Study Comparing Tirelizumab in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Did Not Progress With First-line Immunotherapy Combined With Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan 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
    To evaluate the efficacy and safety of low-dose decitabine combined with tirelizumab in the treatment of patients with advanced esophageal squamous cell carcinoma who did not progress in first-line immunotherapy combined with chemotherapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    low-dose decitabine combined with tirelizumab
    Arm Type
    Experimental
    Arm Description
    Injection site citabine, 10 mg/ bottle, 10 mg/d, Q3W, D1-D5 intravenous infusion; Tirelizumab injection 200mg D5 intravenous infusion.
    Arm Title
    tirelizumab
    Arm Type
    Active Comparator
    Arm Description
    Tirelizumab injection, 10ml: 100mg/1 bottle, 200mg, Q3W, D1 IV infusion.
    Intervention Type
    Drug
    Intervention Name(s)
    Decitabine Injection
    Other Intervention Name(s)
    tirelizumab
    Intervention Description
    Injection site citabine, 10 mg/ bottle, 10 mg/d, Q3W, D1-D5 intravenous infusion; Tirelizumab injection 200mg D5 intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    tirelizumab
    Intervention Description
    10ml: 100mg / 1 bottle, 200mg, Q3W, D1 i. v. infusion.
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    Progression-Free Survival
    Time Frame
    At the end of last Cycle (each cycle is 21 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects voluntarily participate and sign written informed consent; Age ≥18 years; Confirmed by histopathology and/or cytology as esophageal squamous cell carcinoma; At least one measurable lesion according to AJCC 8th staging and RECIST 1.1 solid tumor evaluation criteria. Those who have received immunocheckpoint inhibitors combined with chemotherapy (e.g., paclitaxel + cisplatin) in the first line, and the disease has not progressed; Good functioning of major organs, no serious uncontrolled hypertension, diabetes and heart disease, that is, the relevant indicators within 14 days before treatment meet the following requirements: ANC≥1.2×109/L and lymphocyte count ≥0.5×109/L without the support of granulocyte colony stimulating factor; Without blood transfusion, patients with platelet count ≥100×109/L and hemoglobin ≥90g/L can meet the criteria through blood transfusion; AST, ALT and ALP≤2.5× upper limit of normal (ULN), total bile red ≤1.5×ULN, except the following conditions: for known Gilbert patients: total bilirubin ≤3×ULN, creatinine ≤1.5×ULN, albumin ≥25g/L; For patients not receiving anticoagulant therapy: INR and aPTT≤1.5×ULN. estimated survival ≥3 months; Score of ECOG physical strength: 0~1; The ability of patients to follow the study protocol according to the judgment of the investigator. Exclusion Criteria: Previous immunotherapy; no measurable lesions; There are small cell carcinoma, adenocarcinoma or mixed carcinoma components in the histology; Complete esophageal obstruction; Any NCI CTCAE≥ Grade 2 toxicity that has not recovered after previous chemotherapy; High risk of esophageal fistula was found through clinical evaluation or imaging examination, such as history of esophageal fistula or related symptoms, or primary tumor infiltration into large blood vessels or trachea; had positive detection for EB virus (EBV) capsid antigen IgM during screening (PCR method); If a patient requires analgesic treatment, the treatment regimen used at the time of enrollment must be stable; The men who have HIV positive results at the time of screening; people who test positive for hepatitis C virus (HCV) during sieving; HBV positive screening, and cccDNA≥500 IU/mL; Any of the following diseases in the 12 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident; Pregnant or lactating women or fertile but did not take contraceptive measures; suffer any other serious physical or mental problem of an acute or chronic nature; judging by the researchers, that doesn't fit to participate in the study. -

    12. IPD Sharing Statement

    Learn more about this trial

    Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

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