Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03434379 · OUTCOME

Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma · Source last updated 2023-10-23

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
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

What was measured

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

Analysis population: The analysis population included China participants with a confirmed response (CR or PR).

Groups in this outcome

Sorafenib - China

Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Atezolizumab + Bevacizumab - China

Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

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

Analysis denominator · Participants

GroupSource count
Sorafenib - China4
Atezolizumab + Bevacizumab - China32

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - ChinaNANot reported4.86NANA = not estimable due to the limited number of events observed
Atezolizumab + Bevacizumab - ChinaNANot reported8.15NANA = not estimable due to the limited number of events observed

Source statistical analyses

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

  1. ci Lower Limit
    0.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.85
    group Description
    Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4581
    param Type
    Hazard Ratio (HR)
    param Value
    0.37
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.85
    group Description
    Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4581
    param Type
    Hazard Ratio (HR)
    param Value
    0.37
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG000
        lower Limit
        4.86
        upper Limit
        NA
        value
        NA
      2. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG001
        lower Limit
        8.15
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      32
    units
    Participants
description
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG000
    title
    Sorafenib - China
  2. description
    Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG001
    title
    Atezolizumab + Bevacizumab - China
param Type
MEDIAN
population Description
The analysis population included China participants with a confirmed response (CR or PR).
reporting Status
POSTED
time Frame
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
title
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice