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NCT03581786 · FLOW

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The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer · Source last updated 2025-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles. During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
    id
    FG000
    title
    Placebo Combine With Chemotherapy
  2. description
    In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles . During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
    id
    FG001
    title
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        47
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      reason other than specified above
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        146
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        89
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        57
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles. During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
    id
    FG000
    title
    Placebo Combine With Chemotherapy
  2. description
    In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles . During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
    id
    FG001
    title
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        47
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      reason other than specified above
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        146
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        89
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        57
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice