Participant flow

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.

groups

1. description

   Participants received tislelizumab 200 milligrams (mg) administered intravenously (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. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).

   id

   FG000

   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. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).

   id

   FG001

   title

   Placebo + Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         252

      2. group Id

         FG001

         num Subjects

         268

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         21

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         6

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         28

      type

      Sponsor Ended Study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         326

      2. group Id

         FG001

         num Subjects

         323

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         324

      2. group Id

         FG001

         num Subjects

         321

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         326

      2. group Id

         FG001

         num Subjects

         323

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomly assigned (1:1), using an interactive response technology system, to either tislelizumab plus investigator-chosen chemotherapy or placebo plus investigator-chosen chemotherapy. Randomization was stratified by investigator-chosen chemotherapy (platinum plus fluoropyrimidine vs platinum plus paclitaxel), region (Asia \[excluding Japan\] vs Japan vs other regions), and previous definitive therapy (yes vs no).

recruitment Details

This study was conducted at 162 centers in 16 countries/regions across Asia, Europe, North America, and Oceania.

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Preserved source evidence · Not medical advice