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Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Primary Purpose

Gastric Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Camrelizumab Nab-Paclitaxel S-1
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. None previous chemotherapy, radiotherapy and other antitumor therapy;
  2. Age:18 to 70 years old;
  3. Man or female (except pregnant and lactating women);
  4. Confirmed to gastric adenocarcinoma and HER2-negative;
  5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
  6. Blood cell count has to meet the following certeria:

    WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;

  7. Liver/kidney function has to meet the following certeria:

    ALT and AST≤2.5×ULN TBIL<1.5×ULN; Serum creatinine ≤1.5×ULN;

  8. Left ventricular ejection fraction (LVEF) ≥50%;
  9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  10. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

  1. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
  2. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
  3. Patients with other malignant tumors within 5 years;
  4. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
  5. Distant metastasis;
  6. It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
  7. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
  8. Patients with severe or uncontrollable mental illness;
  9. It have serious harm to the patient's safety or affect the patients who have completed the research.
  10. The researchers think inappropriate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental

    Arm Description

    Camrelizumab: 200mg,iv,30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1:According to the body surface area, BSA <1.25m2,40mg bid; 1.25m2≤BSA≤1.5m2,50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator.

    Outcomes

    Primary Outcome Measures

    R0-resection rate
    There was no residual by the microscope
    Conversion to negative rate
    Exfoliative cytology positive gastric cancer conversion to negative rate

    Secondary Outcome Measures

    Overall survival (OS)
    Baseline to measured date of death from any cause
    Progression free survival (PFS)
    Baseline to measured date of progression or death from any cause
    Objective response rate (ORR)
    Baseline to measured stable disease
    Disease control rate (DCR)
    Baseline to measured progressive disease
    Tumor regression grade (TRG)
    TRG included four grades: Grade 0-3
    Adverse events
    Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit.

    Full Information

    First Posted
    June 6, 2022
    Last Updated
    June 20, 2022
    Sponsor
    Hebei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05410847
    Brief Title
    Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
    Official Title
    A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hebei Medical 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 purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.

    6. Conditions and Keywords

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

    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
    Camrelizumab: 200mg,iv,30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1:According to the body surface area, BSA <1.25m2,40mg bid; 1.25m2≤BSA≤1.5m2,50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator.
    Intervention Type
    Drug
    Intervention Name(s)
    Camrelizumab Nab-Paclitaxel S-1
    Intervention Description
    Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel
    Primary Outcome Measure Information:
    Title
    R0-resection rate
    Description
    There was no residual by the microscope
    Time Frame
    within 3 weeks after surgery
    Title
    Conversion to negative rate
    Description
    Exfoliative cytology positive gastric cancer conversion to negative rate
    Time Frame
    within 3 weeks after surgery
    Secondary Outcome Measure Information:
    Title
    Overall survival (OS)
    Description
    Baseline to measured date of death from any cause
    Time Frame
    3years
    Title
    Progression free survival (PFS)
    Description
    Baseline to measured date of progression or death from any cause
    Time Frame
    3years
    Title
    Objective response rate (ORR)
    Description
    Baseline to measured stable disease
    Time Frame
    tumor assessment every 6 weeks since the treatment began,up to 3years
    Title
    Disease control rate (DCR)
    Description
    Baseline to measured progressive disease
    Time Frame
    tumor assessment every 6 weeks since the treatment began,up to 3years
    Title
    Tumor regression grade (TRG)
    Description
    TRG included four grades: Grade 0-3
    Time Frame
    within 3 weeks after surgery
    Title
    Adverse events
    Description
    Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit.
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: None previous chemotherapy, radiotherapy and other antitumor therapy; Age:18 to 70 years old; Man or female (except pregnant and lactating women); Confirmed to gastric adenocarcinoma and HER2-negative; Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive; Blood cell count has to meet the following certeria: WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L; Liver/kidney function has to meet the following certeria: ALT and AST≤2.5×ULN TBIL<1.5×ULN; Serum creatinine ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥50%; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Participants were willing to join in this study, good adherence and written informed consent. Exclusion Criteria: Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); Patients with other malignant tumors within 5 years; Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study; Distant metastasis; It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on); History of psychiatric drugs abuse and can't quit or patients with mental disorders; Patients with severe or uncontrollable mental illness; It have serious harm to the patient's safety or affect the patients who have completed the research. The researchers think inappropriate.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qun Zhao, Professor
    Phone
    13930162111
    Email
    Zhaoqun516@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

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