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NCT03777657 · BASELINE

Baseline characteristics

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma · Source last updated 2025-02-14

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
      501
    2. group Id
      BG001
      value
      496
    3. group Id
      BG002
      value
      997
    units
    Participants
groups
  1. description
    Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Tislelizumab + Chemotherapy
  2. description
    Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    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
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          340
        2. group Id
          BG001
          value
          313
        3. group Id
          BG002
          value
          653
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          183
        3. group Id
          BG002
          value
          344
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.07
          value
          58.8
        2. group Id
          BG001
          spread
          11.20
          value
          59.7
        3. group Id
          BG002
          spread
          11.14
          value
          59.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          305
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          346
        2. group Id
          BG001
          value
          346
        3. group Id
          BG002
          value
          692
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          492
        2. group Id
          BG001
          value
          474
        3. group Id
          BG002
          value
          966
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          23
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          376
        2. group Id
          BG001
          value
          372
        3. group Id
          BG002
          value
          748
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          223
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          24
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          257
        3. group Id
          BG002
          value
          516
        title
        China (including Taiwan)
      2. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          232
        title
        Japan and South Korea
      3. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          249
        title
        North America/Europe
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          405
        2. group Id
          BG001
          value
          395
        3. group Id
          BG002
          value
          800
        title
        Stomach
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          196
        title
        Gastro-oesophageal junction
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Other*
    description
    \*One participant in the placebo + chemotherapy arm did not report primary location and disease stage, as the diagnosis of this participant was updated from gastric adenocarcinoma to be pancreatic cancer after randomization.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Location
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          451
        title
        < 5%
      2. measurements
        1. group Id
          BG000
          value
          274
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          546
        title
        ≥ 5%
    description
    PDL1 expression was assessed by a central laboratory using the 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 an investigational use only version of the Ventana PDL1 (SP263) assay.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Expression
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          220
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          434
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          281
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          563
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Presence of Peritoneal Metastasis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          466
        2. group Id
          BG001
          value
          465
        3. group Id
          BG002
          value
          931
        title
        Oxaliplatin + Capecitabine
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Cisplatin + 5-Fluorouracil
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Chosen Chemotherapy
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      501
    2. group Id
      BG001
      value
      496
    3. group Id
      BG002
      value
      997
    units
    Participants
groups
  1. description
    Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Tislelizumab + Chemotherapy
  2. description
    Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    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
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          340
        2. group Id
          BG001
          value
          313
        3. group Id
          BG002
          value
          653
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          183
        3. group Id
          BG002
          value
          344
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.07
          value
          58.8
        2. group Id
          BG001
          spread
          11.20
          value
          59.7
        3. group Id
          BG002
          spread
          11.14
          value
          59.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          305
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          346
        2. group Id
          BG001
          value
          346
        3. group Id
          BG002
          value
          692
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          492
        2. group Id
          BG001
          value
          474
        3. group Id
          BG002
          value
          966
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          23
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          376
        2. group Id
          BG001
          value
          372
        3. group Id
          BG002
          value
          748
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          223
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          24
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          257
        3. group Id
          BG002
          value
          516
        title
        China (including Taiwan)
      2. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          232
        title
        Japan and South Korea
      3. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          249
        title
        North America/Europe
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          405
        2. group Id
          BG001
          value
          395
        3. group Id
          BG002
          value
          800
        title
        Stomach
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          196
        title
        Gastro-oesophageal junction
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Other*
    description
    \*One participant in the placebo + chemotherapy arm did not report primary location and disease stage, as the diagnosis of this participant was updated from gastric adenocarcinoma to be pancreatic cancer after randomization.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Location
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          451
        title
        < 5%
      2. measurements
        1. group Id
          BG000
          value
          274
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          546
        title
        ≥ 5%
    description
    PDL1 expression was assessed by a central laboratory using the 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 an investigational use only version of the Ventana PDL1 (SP263) assay.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Expression
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          220
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          434
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          281
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          563
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Presence of Peritoneal Metastasis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          466
        2. group Id
          BG001
          value
          465
        3. group Id
          BG002
          value
          931
        title
        Oxaliplatin + Capecitabine
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Cisplatin + 5-Fluorouracil
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Chosen Chemotherapy
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice