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NCT03430843 · OUTCOME

Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma · Source last updated 2024-10-26

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

What was measured

ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;

Analysis population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%

Groups in this outcome

Tislelizumab

Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.

Investigator Chosen Chemotherapy

Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Tislelizumab80
Investigator Chosen Chemotherapy62

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab26.3Not reported1737.3Not reported
Investigator Chosen Chemotherapy11.3Not reported4.721.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17
        upper Limit
        37.3
        value
        26.3
      2. group Id
        OG001
        lower Limit
        4.7
        upper Limit
        21.9
        value
        11.3
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    2. group Id
      OG001
      value
      62
    units
    Participants
description
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
dispersion Type
95% Confidence Interval
groups
  1. description
    Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
    id
    OG000
    title
    Tislelizumab
  2. description
    Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
    id
    OG001
    title
    Investigator Chosen Chemotherapy
param Type
NUMBER
population Description
The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%
reporting Status
POSTED
time Frame
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
title
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice