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NCT03777657 · FLOW

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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.

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. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. 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
    FG000
    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. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. 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
    FG001
    title
    Placebo + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        397
      2. group Id
        FG001
        num Subjects
        431
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        38
      type
      Study Closed by Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        17
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        10
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        501
      2. group Id
        FG001
        num Subjects
        496
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        498
      2. group Id
        FG001
        num Subjects
        494
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        500
      2. group Id
        FG001
        num Subjects
        496
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomly assigned to either tislelizumab plus investigator chosen chemotherapy (ICC) or placebo plus ICC. Randomization was stratified according to region (China \[including Taiwan\] vs Japan and South Korea vs Europe/North America), programmed cell death protein ligand-1 (PD-L1) expression (PDL1 tumor area positivity (TAP) score ≥5% or \<5%), peritoneal metastases (yes vs no), and investigator's choice of chemotherapy (capecitabine + oxaliplatin, or 5-fluorouracil + cisplatin).
recruitment Details
This study was conducted at 141 study centers in 13 countries across Asia, Europe, and North America. Adults with histologically confirmed, locally advanced unresectable or metastatic gastric or gastrooesophageal junction adenocarcinoma and no previous systemic therapy for advanced disease were recruited.
Complete source fields
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. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. 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
    FG000
    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. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. 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
    FG001
    title
    Placebo + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        397
      2. group Id
        FG001
        num Subjects
        431
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        38
      type
      Study Closed by Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        17
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        10
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        501
      2. group Id
        FG001
        num Subjects
        496
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        498
      2. group Id
        FG001
        num Subjects
        494
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        500
      2. group Id
        FG001
        num Subjects
        496
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomly assigned to either tislelizumab plus investigator chosen chemotherapy (ICC) or placebo plus ICC. Randomization was stratified according to region (China \[including Taiwan\] vs Japan and South Korea vs Europe/North America), programmed cell death protein ligand-1 (PD-L1) expression (PDL1 tumor area positivity (TAP) score ≥5% or \<5%), peritoneal metastases (yes vs no), and investigator's choice of chemotherapy (capecitabine + oxaliplatin, or 5-fluorouracil + cisplatin).
recruitment Details
This study was conducted at 141 study centers in 13 countries across Asia, Europe, and North America. Adults with histologically confirmed, locally advanced unresectable or metastatic gastric or gastrooesophageal junction adenocarcinoma and no previous systemic therapy for advanced disease were recruited.

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Preserved source evidence · Not medical advice