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Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence

Primary Purpose

Esophageal Malignant Neoplasm, Local Recurrence

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Procedural death 1
Capecitabine
Radiotherapy
Placebo
Sponsored by
The First Affiliated Hospital of Henan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Malignant Neoplasm, Local Recurrence focused on measuring Carrillizumab, Esophageal cancer recurred, concurrent radiochemotherapy

Eligibility Criteria

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

Inclusion Criteria:

1.Age 18-75 years old, both men and women; 2. Histologically confirmed as esophageal squamous cell carcinoma; 3. Postoperative local recurrence of esophageal cancer (stage II-IVA); 4. According to the evaluation criteria of RECIST 1.1, at least one measurable lesion; 5. ECOG: 0 ~ 1; 6. Expected survival time ≥ 12 weeks; 7. The function of main organs is normal, that is, it meets the following standards: Blood routine examination:a. HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L;3.Biochemical inspection:a.ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; c. TBIL ≤ 1.5ULN; 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days before the study enrollment , and must be a non-lactating patient; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 9. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

  1. Does not meet the above selection criteria;
  2. Patients with distant metastases;
  3. Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;
  4. The patient has any active autoimmune disease or has 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; The patient has vitiligo; Asthma has been completely relieved in childhood and can be included without any intervention after adulthood; Patients with asthma requiring medical intervention with bronchodilators cannot be included);
  5. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose> 10mg / day prednisone or other therapeutic hormones), and is still using it within 2 weeks before enrollment; 6. Contraindications to radiotherapy;

7. Severe infections that are active or uncontrolled; 8. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analytical method; 9. Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study; 10. Pregnant or lactating women; 11. Patients with other malignant tumors within 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ); 12. Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders; 13. Patients who have participated in clinical trials of other drugs within four weeks; 14. According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 15. The investigator considers it unsuitable for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    PD-1 and Concurrent chemoradiotherapy

    placebo and Concurrent chemoradiotherapy

    Arm Description

    Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin:65mg/m2,d1,8,22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.

    placebo: 200mg,d1,15,29,43,57,I.V oxaliplatin:65mg/m2,d1,8,22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.

    Outcomes

    Primary Outcome Measures

    Grade 3/4 acute toxicities
    rade 3/4 acute toxicities occurred during or within 90 days after CRT
    PFS
    Progression Free Survival After completion of the CRT

    Secondary Outcome Measures

    ORR
    overall remission rate
    OS Qol
    overall survival

    Full Information

    First Posted
    May 15, 2020
    Last Updated
    May 21, 2020
    Sponsor
    The First Affiliated Hospital of Henan University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04404491
    Brief Title
    Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence
    Official Title
    The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    December 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Henan University of Science and Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Esophageal cancer is still a serious threat to human life and health. China in particular. Relapse and metastasis are important causes of treatment failure. Immunotherapy is a new treatment method, which can be used in combination with chemotherapy to improve the therapeutic effect. However, the role of immunotherapy combined with chemoradiotherapy in concurrent chemoradiotherapy of recurrent esophageal cancer has not been clearly studied. Our team will study it in detail. The purpose of this study was to compare and analyze the effect of Camrelizumab in concurrent chemoradiotherapy of locally recurrent esophageal cancer.
    Detailed Description
    In this study, patients with local recurrence of esophageal carcinoma without distant metastasis were randomly divided into experimental group and control group by Block randomization. In the experimental group, patients with local recurrence were treated with Camrelizumab combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival. In the control group, patients with local recurrence were treated with placebo combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Malignant Neoplasm, Local Recurrence
    Keywords
    Carrillizumab, Esophageal cancer recurred, concurrent radiochemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PD-1 and Concurrent chemoradiotherapy
    Arm Type
    Active Comparator
    Arm Description
    Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin:65mg/m2,d1,8,22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.
    Arm Title
    placebo and Concurrent chemoradiotherapy
    Arm Type
    Placebo Comparator
    Arm Description
    placebo: 200mg,d1,15,29,43,57,I.V oxaliplatin:65mg/m2,d1,8,22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.
    Intervention Type
    Drug
    Intervention Name(s)
    Procedural death 1
    Other Intervention Name(s)
    Camrelizumab
    Intervention Description
    200mg,d1,15,29,43,57,I.V
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine
    Other Intervention Name(s)
    Aibin
    Intervention Description
    Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiotherapy
    Other Intervention Name(s)
    Radiation Therapy
    Intervention Description
    radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo: 200mg,d1,15,29,43,57,I.V
    Primary Outcome Measure Information:
    Title
    Grade 3/4 acute toxicities
    Description
    rade 3/4 acute toxicities occurred during or within 90 days after CRT
    Time Frame
    90 days
    Title
    PFS
    Description
    Progression Free Survival After completion of the CRT
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    ORR
    Description
    overall remission rate
    Time Frame
    16 weeks
    Title
    OS Qol
    Description
    overall survival
    Time Frame
    1 year

    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: 1.Age 18-75 years old, both men and women; 2. Histologically confirmed as esophageal squamous cell carcinoma; 3. Postoperative local recurrence of esophageal cancer (stage II-IVA); 4. According to the evaluation criteria of RECIST 1.1, at least one measurable lesion; 5. ECOG: 0 ~ 1; 6. Expected survival time ≥ 12 weeks; 7. The function of main organs is normal, that is, it meets the following standards: Blood routine examination:a. HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L;3.Biochemical inspection:a.ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; c. TBIL ≤ 1.5ULN; 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days before the study enrollment , and must be a non-lactating patient; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 9. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up. Exclusion Criteria: Does not meet the above selection criteria; Patients with distant metastases; Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab; The patient has any active autoimmune disease or has 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; The patient has vitiligo; Asthma has been completely relieved in childhood and can be included without any intervention after adulthood; Patients with asthma requiring medical intervention with bronchodilators cannot be included); The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose> 10mg / day prednisone or other therapeutic hormones), and is still using it within 2 weeks before enrollment; 6. Contraindications to radiotherapy; 7. Severe infections that are active or uncontrolled; 8. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analytical method; 9. Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study; 10. Pregnant or lactating women; 11. Patients with other malignant tumors within 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ); 12. Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders; 13. Patients who have participated in clinical trials of other drugs within four weeks; 14. According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 15. The investigator considers it unsuitable for inclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shegan Gao, M.D,Ph.D
    Phone
    18638859977
    Email
    gsg112258@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tanyou Shan, M.D,M.S
    Phone
    18537976669
    Email
    shantanyou@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shegan Gao, M.D,Ph.D
    Organizational Affiliation
    The First Affiliated Hospital of Henan University of Science and Technology
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence

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