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To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer

Primary Purpose

Colon Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Envafolimab
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring locally advanced colon cance, Envafolimab

Eligibility Criteria

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

Inclusion Criteria:

  1. Histological confirmation of colon adenocarcinoma
  2. Radiological signs, evaluated by CT, of T4 or Tany N+ (AJCC 8th) 3 No metastatic involvement in other organs (M0). 4 Uncomplicated primary tumor 5 Patients who have not received systemic chemotherapy or other anti-tumor treatment 6 18-75 years; 7 ECOG 0-1; 8 The patient must have adequate organ function and meet the following laboratory test values during the screening period within 7 days before enrolling:

    • Absolute neutrophil cell count (ANC) ≥1.5x109/L, platelet ≥75x109/L, hemoglobin ≥90g/L.(in (Patients with no blood transfusion or growth factor support should be given for 7 days prior to blood collection.)
    • Serum creatinine ≤1.5× upper normal range (ULN) or estimated creatinine clearance ≥50mL/min, Glutamate aminotransferase and glutamate aminotransferase (AST and ALT)≤3×ULN.
    • Total bilirubin ≤1.5×ULN;If there is Gilbert syndrome or if the indirect bilirubin concentration indicates an extrahepatic source of bile The rise of erythrosin is ≤3×ULN.
    • Aptt ≤1.5×ULN, and INR or PT≤1.5×ULN. 9 Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed 10 Sign written informed consent. 11 Expected overall survival ≥3 months 12 A person is operation and compliance with medical treatment

Exclusion Criteria:

  1. Known to be allergic to any study drug
  2. The patient has a history of autoimmune disease
  3. Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment.
  4. The patient has severe active infections
  5. A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive 6、Patients Have high blood pressure that cannot be well controlled by antihypertensive medication or any other uncontrolled disease

7 pregnant women or Lactating women 8 The patient has mental illness and cannot comply with the study regulations 9 According to the judgment of the researcher, the patient have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Envafolimab combined with XELOX regimen

    Arm Description

    Envafolimab:300mg,sc,d1,Q3W XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)

    Outcomes

    Primary Outcome Measures

    TRG0/1
    the rate of Tumor Regression Grading level 0/1

    Secondary Outcome Measures

    R0 resection rate
    The tumor was completely removed, and the cutting edge was negative under microscope, without tumor residue
    ORR
    Objective response rate

    Full Information

    First Posted
    April 13, 2022
    Last Updated
    April 13, 2022
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05335460
    Brief Title
    To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer
    Official Title
    Envafolimab Combined With XELOX in Neoadjuvant Therapy for Locally Advanced Colon Cancer,A Prospective, Single Arm, Single Center ǁ Phase Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    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 objective is to investigate the efficacy and safety of Envafolimab combined with XELOX in neoadjuvant therapy for locally advanced colon cancer
    Detailed Description
    According to the 2019 NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment. This study is a single-center, single-arm phase II study, patients received neoadjuvant therapy with Envafolimab combined with XELOX regimen, with one treatment cycle every 3 weeks and after two cycles accept surgery. To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer
    Keywords
    locally advanced colon cance, Envafolimab

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Envafolimab combined with XELOX regimen
    Arm Type
    Experimental
    Arm Description
    Envafolimab:300mg,sc,d1,Q3W XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)
    Intervention Type
    Drug
    Intervention Name(s)
    Envafolimab
    Other Intervention Name(s)
    XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)
    Intervention Description
    300mg,sc,d1,Q3W
    Primary Outcome Measure Information:
    Title
    TRG0/1
    Description
    the rate of Tumor Regression Grading level 0/1
    Time Frame
    within 7 days after surgery
    Secondary Outcome Measure Information:
    Title
    R0 resection rate
    Description
    The tumor was completely removed, and the cutting edge was negative under microscope, without tumor residue
    Time Frame
    within 7 days after surgery
    Title
    ORR
    Description
    Objective response rate
    Time Frame
    within 1 year after surgery
    Other Pre-specified Outcome Measures:
    Title
    PCR rate
    Description
    There were no residual tumor cells under microscope
    Time Frame
    within 7 days after surgery

    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: Histological confirmation of colon adenocarcinoma Radiological signs, evaluated by CT, of T4 or Tany N+ (AJCC 8th) 3 No metastatic involvement in other organs (M0). 4 Uncomplicated primary tumor 5 Patients who have not received systemic chemotherapy or other anti-tumor treatment 6 18-75 years; 7 ECOG 0-1; 8 The patient must have adequate organ function and meet the following laboratory test values during the screening period within 7 days before enrolling: Absolute neutrophil cell count (ANC) ≥1.5x109/L, platelet ≥75x109/L, hemoglobin ≥90g/L.(in (Patients with no blood transfusion or growth factor support should be given for 7 days prior to blood collection.) Serum creatinine ≤1.5× upper normal range (ULN) or estimated creatinine clearance ≥50mL/min, Glutamate aminotransferase and glutamate aminotransferase (AST and ALT)≤3×ULN. Total bilirubin ≤1.5×ULN;If there is Gilbert syndrome or if the indirect bilirubin concentration indicates an extrahepatic source of bile The rise of erythrosin is ≤3×ULN. Aptt ≤1.5×ULN, and INR or PT≤1.5×ULN. 9 Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed 10 Sign written informed consent. 11 Expected overall survival ≥3 months 12 A person is operation and compliance with medical treatment Exclusion Criteria: Known to be allergic to any study drug The patient has a history of autoimmune disease Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. The patient has severe active infections A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive 6、Patients Have high blood pressure that cannot be well controlled by antihypertensive medication or any other uncontrolled disease 7 pregnant women or Lactating women 8 The patient has mental illness and cannot comply with the study regulations 9 According to the judgment of the researcher, the patient have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zaisheng Ye
    Phone
    13950203076
    Email
    flyingengel@sina.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer

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