Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03783442 · BASELINE

Baseline characteristics

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma · Source last updated 2025-07-29

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

denoms
  1. counts
    1. group Id
      BG000
      value
      326
    2. group Id
      BG001
      value
      323
    3. group Id
      BG002
      value
      649
    units
    Participants
groups
  1. description
    Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
    id
    BG000
    title
    Tislelizumab + Chemotherapy
  2. description
    Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
    id
    BG001
    title
    Placebo + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          84
          value
          64.0
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          84
          value
          65.0
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          84
          value
          64.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          86
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          282
        2. group Id
          BG001
          value
          281
        3. group Id
          BG002
          value
          563
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          243
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          486
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          155
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          420
        title
        Asia (excluding Japan)
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          66
        title
        Japan
      3. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          163
        title
        Rest of World
    description
    Rest of World includes Europe, North America and Oceania.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          302
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          347
      title
      No
    description
    A tumor that is localized without distant metastases is treated with definitive therapy with the intention to cure, and may have included chemotherapy, radiotherapy and/or surgery.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Definitive Therapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          293
      title
      Platinum with Fluoropyrimidine
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          356
      title
      Platinum with Paclitaxel
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Chosen Chemotherapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          223
      title
      PD-L1 Score ≥ 10%
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          168
        3. group Id
          BG002
          value
          319
      title
      PD-L1 Score < 10%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          107
      title
      Unknown
    description
    PD-L1 is a protein found on some normal cells and in higher-than-normal amounts on certain cancer cells that can block the immune system from attacking cancer cells. PD-L1 expression was assessed by a central laboratory using the tumor area positivity (TAP) score, defined as total percentage of tumor area (tumor and any desmoplastic stroma) covered by tumor cells with PD-L1 membrane staining (any intensity), and tumor associated immune cells with PD-L1 staining (any intensity), visually estimated by pathologists using the Ventana PD-L1 (SP263) assay.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death Protein Ligand-1 (PD-L1) Expression
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) analysis set included all randomized participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      326
    2. group Id
      BG001
      value
      323
    3. group Id
      BG002
      value
      649
    units
    Participants
groups
  1. description
    Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
    id
    BG000
    title
    Tislelizumab + Chemotherapy
  2. description
    Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
    id
    BG001
    title
    Placebo + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          84
          value
          64.0
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          84
          value
          65.0
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          84
          value
          64.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          86
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          282
        2. group Id
          BG001
          value
          281
        3. group Id
          BG002
          value
          563
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          243
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          486
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          155
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          420
        title
        Asia (excluding Japan)
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          66
        title
        Japan
      3. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          163
        title
        Rest of World
    description
    Rest of World includes Europe, North America and Oceania.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          302
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          347
      title
      No
    description
    A tumor that is localized without distant metastases is treated with definitive therapy with the intention to cure, and may have included chemotherapy, radiotherapy and/or surgery.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Definitive Therapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          293
      title
      Platinum with Fluoropyrimidine
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          356
      title
      Platinum with Paclitaxel
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Chosen Chemotherapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          223
      title
      PD-L1 Score ≥ 10%
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          168
        3. group Id
          BG002
          value
          319
      title
      PD-L1 Score < 10%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          107
      title
      Unknown
    description
    PD-L1 is a protein found on some normal cells and in higher-than-normal amounts on certain cancer cells that can block the immune system from attacking cancer cells. PD-L1 expression was assessed by a central laboratory using the tumor area positivity (TAP) score, defined as total percentage of tumor area (tumor and any desmoplastic stroma) covered by tumor cells with PD-L1 membrane staining (any intensity), and tumor associated immune cells with PD-L1 staining (any intensity), visually estimated by pathologists using the Ventana PD-L1 (SP263) assay.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death Protein Ligand-1 (PD-L1) Expression
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) analysis set included all randomized participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice