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NCT03875235 · OUTCOME

Overall Survival (OS)

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) · Source last updated 2026-08-26

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)

What was measured

Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).

Analysis population: Full analysis set

Groups in this outcome

Durvalumab + Gemcitabine + Cisplatin

Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Placebo + Gemcitabine + Cisplatin

Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

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

Analysis denominator · Participants

GroupSource count
Durvalumab + Gemcitabine + Cisplatin341
Placebo + Gemcitabine + Cisplatin344

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durvalumab + Gemcitabine + Cisplatin12.8Not reported11.114.0Not reported
Placebo + Gemcitabine + Cisplatin11.5Not reported10.112.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97
    ci Upper Limit
    0.99
    estimate Comment
    The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.
    group Description
    The 2-sided significance level for OS at the second interim analysis was 3%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95% CI 0.66 to 0.97
    p Value
    0.021
    p Value Comment
    The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97
    ci Upper Limit
    0.99
    estimate Comment
    The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.
    group Description
    The 2-sided significance level for OS at the second interim analysis was 3%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95% CI 0.66 to 0.97
    p Value
    0.021
    p Value Comment
    The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        14.0
        value
        12.8
      2. group Id
        OG001
        lower Limit
        10.1
        upper Limit
        12.5
        value
        11.5
denoms
  1. counts
    1. group Id
      OG000
      value
      341
    2. group Id
      OG001
      value
      344
    units
    Participants
description
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
dispersion Type
95% Confidence Interval
groups
  1. description
    Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    OG000
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. description
    Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    OG001
    title
    Placebo + Gemcitabine + Cisplatin
param Type
MEDIAN
population Description
Full analysis set
reporting Status
POSTED
time Frame
From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice