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NCT03298451 · OUTCOME

Duration of Objective Response (DoR)

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2026-07-27

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Inter-Quartile Range
Time frame
From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

What was measured

Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

Analysis population: A subset of FAS subjects who achieve confirmed CR or PR as determined per RECIST 1.1 using Investigator assessment. T75+D arm was closed during study.

Groups in this outcome

Durva 1500 mg

Durvalumab 1500 mg every 4 weeks (Q4W)

Treme 300 mg x1 Dose + Durva 1500 mg

Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W

Treme 75 mg x4 Doses + Durva 1500 mg

Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W

Sora 400 mg

Sorafenib 400 mg twice daily (BID)

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

Analysis denominator · Participants

GroupSource count
Durva 1500 mg66
Treme 300 mg x1 Dose + Durva 1500 mg79
Treme 75 mg x4 Doses + Durva 1500 mg26
Sora 400 mg20

Reported measurements

Duration of response from onset of response
Values in months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Durva 1500 mg16.82Not reported7.43NANot reached
Treme 300 mg x1 Dose + Durva 1500 mg22.34Not reported8.54NANot reached
Treme 75 mg x4 Doses + Durva 1500 mg14.75Not reported7.4614.75Not reported
Sora 400 mg18.43Not reported6.5125.99Not reported
Time to onset of response from randomization
Values in months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Durva 1500 mg2.09Not reported1.873.98Not reported
Treme 300 mg x1 Dose + Durva 1500 mg2.17Not reported1.843.98Not reported
Treme 75 mg x4 Doses + Durva 1500 mg2.02Not reported1.873.71Not reported
Sora 400 mg3.78Not reported1.898.44Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not reached
        group Id
        OG000
        lower Limit
        7.43
        upper Limit
        NA
        value
        16.82
      2. comment
        Not reached
        group Id
        OG001
        lower Limit
        8.54
        upper Limit
        NA
        value
        22.34
      3. group Id
        OG002
        lower Limit
        7.46
        upper Limit
        14.75
        value
        14.75
      4. group Id
        OG003
        lower Limit
        6.51
        upper Limit
        25.99
        value
        18.43
    title
    Duration of response from onset of response
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.87
        upper Limit
        3.98
        value
        2.09
      2. group Id
        OG001
        lower Limit
        1.84
        upper Limit
        3.98
        value
        2.17
      3. group Id
        OG002
        lower Limit
        1.87
        upper Limit
        3.71
        value
        2.02
      4. group Id
        OG003
        lower Limit
        1.89
        upper Limit
        8.44
        value
        3.78
    title
    Time to onset of response from randomization
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      79
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      20
    units
    Participants
description
Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Durvalumab 1500 mg every 4 weeks (Q4W)
    id
    OG000
    title
    Durva 1500 mg
  2. description
    Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W
    id
    OG001
    title
    Treme 300 mg x1 Dose + Durva 1500 mg
  3. description
    Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W
    id
    OG002
    title
    Treme 75 mg x4 Doses + Durva 1500 mg
  4. description
    Sorafenib 400 mg twice daily (BID)
    id
    OG003
    title
    Sora 400 mg
param Type
MEDIAN
population Description
A subset of FAS subjects who achieve confirmed CR or PR as determined per RECIST 1.1 using Investigator assessment. T75+D arm was closed during study.
reporting Status
POSTED
time Frame
From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
title
Duration of Objective Response (DoR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice