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Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tislelizumab
Radiation
Paclitaxel
Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugs
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

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

Inclusion Criteria: Signed a written informed consent and volunteered to join the study; Patients with esophageal squamous cell carcinoma confirmed by pathological histological and / or immunohistochemical examination or progressing after surgical resection, (the 8th edition, 2017) with UICC / AJCC TNM stage cT4N0-2M0, c any TN3M0, or c any T any NM1 (clinical stage IV); Unresectable advanced, recurrent, or metastatic oesophageal SCC; Age: 70 years old; E CO G P S 0-2 Has not received any systemic antitumor treatment for esophageal cancer, including radiotherapy, chemotherapy, targeted, immunotherapy, etc.; At least one measurable lesion was present Main organs have normal function, including: A) Routine blood tests (no blood components, cell growth factors, whitening agents, platelets, anemia drugs are allowed within 14 days before the first use of the study drug) Leukocyte count was at 3.0109/L Neutrophil count was at 1.0109/L Platelet count was at 8,0109/L Hemoglobin was at 80 g / L b) Blood biochemical examination: Total bilirubin was at 1.5 ULN ALT ≤ 2.5×ULN ,AST ≤2.5×ULN , Serum creatinine of 1.5 ULN, or creatinine clearance of 45 mL/min (Cocheroft-Gault formula, see Annex 2) -The subjects had good compliance and cooperated with the follow-up Exclusion Criteria: There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage; Poor nutritional status, BMI <18.5 Kg / m2; if corrected after symptomatic nutritional support, further enrollment can be considered after evaluation by the principal investigator; Gastrointestinal bleeding (bleeding volume> 200ml / day); Patients adjudged by the researchers to have deep ulcers; Previous history of allergy to monoclonal antibodies, any component of tirellizumab, paclitaxel, cisplatin, or other platinum drugs; Has received or are receiving any of the following treatments: A) Any radiotherapy, chemotherapy, or other antitumor drugs directed against the tumor; Study drug b) Treatment with immunosuppressive drugs or systemic hormones for immunosuppression purposes within 2 weeks of the first study drug (dose or equivalent dose> 10mg / day); inhaled or topical steroids and doses> 10mg / day prednisone or equivalent dose of adrenal corticoid replacement in the absence of active autoimmune disease; The c) Acceptance of a live attenuated vaccine within 4 weeks before the first use of the study drug; d) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug; History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after HRT); patients with psoriasis or asthma / allergy in childhood remission and adults without any intervention, but patients requiring bronchodilator are not included; A history of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; Poor clinical cardiac symptoms or disease, including but not limited to: Such as (1) heart failure of grade NYHAII or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinical significance of supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention is not well controlled; Severe infection (CTCAE> 2) within 4 weeks before initial use of study drug, such as severe pneumonia, bacteremia, or infection complications requiring hospitalization; baseline chest imaging indicates active lung inflammation, symptoms or signs of infection within 14 days prior to initial use of study drug, or requiring oral or intravenous antibiotics, except for prophylactic antibiotics; Patients with active tuberculosis infection by medical history or CT examination, or active tuberculosis infection within 1 year prior to enrollment, or active tuberculosis infection within 1 year before enrollment, or before enrollment but without formal treatment; The presence of active hepatitis B (HBV DNA 2000 IU / mL or 104 copies / mL), hepatitis C (hepatitis C antibody positive, and HCV RNA above the lower limit of the analysis method); According to the investigator, there are other factors present that may lead to the forced termination of the study, such as other serious illness (including mental illness) requiring combined treatment, alcohol abuse, substance abuse, family or social factors, that may affect the safety or compliance of the subject.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Tislelizumab combined with radiotherapy

    Tislelizumab combined with chemotherapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    objective response rate
    Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).

    Secondary Outcome Measures

    progression free survival
    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

    Full Information

    First Posted
    November 18, 2022
    Last Updated
    November 18, 2022
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05628610
    Brief Title
    Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer
    Official Title
    Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2027 (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
    To compare the objective response rate (ORR) and safety of tislelizumab combined with chemotherapy and Tislelizumab combined with radiotherapy in elderly patients with esophageal cancer with advanced or recurrent metastasis

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Tislelizumab combined with radiotherapy
    Arm Type
    Experimental
    Arm Title
    Tislelizumab combined with chemotherapy
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab
    Intervention Description
    200mg d1, Q3W
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiation
    Intervention Description
    Radiotherapy dose: 5,000 c G y / 30f
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    Paclitaxel: 150mg / m2 ,d1, q3w
    Intervention Type
    Drug
    Intervention Name(s)
    Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugs
    Intervention Description
    cisplatin, carboplatin, naidaplatin and other platinum drugs
    Primary Outcome Measure Information:
    Title
    objective response rate
    Description
    Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    progression free survival
    Description
    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed a written informed consent and volunteered to join the study; Patients with esophageal squamous cell carcinoma confirmed by pathological histological and / or immunohistochemical examination or progressing after surgical resection, (the 8th edition, 2017) with UICC / AJCC TNM stage cT4N0-2M0, c any TN3M0, or c any T any NM1 (clinical stage IV); Unresectable advanced, recurrent, or metastatic oesophageal SCC; Age: 70 years old; E CO G P S 0-2 Has not received any systemic antitumor treatment for esophageal cancer, including radiotherapy, chemotherapy, targeted, immunotherapy, etc.; At least one measurable lesion was present Main organs have normal function, including: A) Routine blood tests (no blood components, cell growth factors, whitening agents, platelets, anemia drugs are allowed within 14 days before the first use of the study drug) Leukocyte count was at 3.0109/L Neutrophil count was at 1.0109/L Platelet count was at 8,0109/L Hemoglobin was at 80 g / L b) Blood biochemical examination: Total bilirubin was at 1.5 ULN ALT ≤ 2.5×ULN ,AST ≤2.5×ULN , Serum creatinine of 1.5 ULN, or creatinine clearance of 45 mL/min (Cocheroft-Gault formula, see Annex 2) -The subjects had good compliance and cooperated with the follow-up Exclusion Criteria: There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage; Poor nutritional status, BMI <18.5 Kg / m2; if corrected after symptomatic nutritional support, further enrollment can be considered after evaluation by the principal investigator; Gastrointestinal bleeding (bleeding volume> 200ml / day); Patients adjudged by the researchers to have deep ulcers; Previous history of allergy to monoclonal antibodies, any component of tirellizumab, paclitaxel, cisplatin, or other platinum drugs; Has received or are receiving any of the following treatments: A) Any radiotherapy, chemotherapy, or other antitumor drugs directed against the tumor; Study drug b) Treatment with immunosuppressive drugs or systemic hormones for immunosuppression purposes within 2 weeks of the first study drug (dose or equivalent dose> 10mg / day); inhaled or topical steroids and doses> 10mg / day prednisone or equivalent dose of adrenal corticoid replacement in the absence of active autoimmune disease; The c) Acceptance of a live attenuated vaccine within 4 weeks before the first use of the study drug; d) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug; History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after HRT); patients with psoriasis or asthma / allergy in childhood remission and adults without any intervention, but patients requiring bronchodilator are not included; A history of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; Poor clinical cardiac symptoms or disease, including but not limited to: Such as (1) heart failure of grade NYHAII or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinical significance of supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention is not well controlled; Severe infection (CTCAE> 2) within 4 weeks before initial use of study drug, such as severe pneumonia, bacteremia, or infection complications requiring hospitalization; baseline chest imaging indicates active lung inflammation, symptoms or signs of infection within 14 days prior to initial use of study drug, or requiring oral or intravenous antibiotics, except for prophylactic antibiotics; Patients with active tuberculosis infection by medical history or CT examination, or active tuberculosis infection within 1 year prior to enrollment, or active tuberculosis infection within 1 year before enrollment, or before enrollment but without formal treatment; The presence of active hepatitis B (HBV DNA 2000 IU / mL or 104 copies / mL), hepatitis C (hepatitis C antibody positive, and HCV RNA above the lower limit of the analysis method); According to the investigator, there are other factors present that may lead to the forced termination of the study, such as other serious illness (including mental illness) requiring combined treatment, alcohol abuse, substance abuse, family or social factors, that may affect the safety or compliance of the subject.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer

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