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NCT03298451 · OUTCOME

EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration

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
95% Confidence Interval
Time frame
At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

What was measured

European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

Analysis population: A subset of the FAS who had baseline scores of \>=10. 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 mg319
Treme 300 mg x1 Dose + Durva 1500 mg302
Treme 75 mg x4 Doses + Durva 1500 mg132
Sora 400 mg323

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durva 1500 mg7.4Not reported5.689.33Not reported
Treme 300 mg x1 Dose + Durva 1500 mg7.5Not reported5.8210.84Not reported
Treme 75 mg x4 Doses + Durva 1500 mg7.3Not reported5.659.33Not reported
Sora 400 mg5.7Not reported4.807.39Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.68
        upper Limit
        9.33
        value
        7.4
      2. group Id
        OG001
        lower Limit
        5.82
        upper Limit
        10.84
        value
        7.5
      3. group Id
        OG002
        lower Limit
        5.65
        upper Limit
        9.33
        value
        7.3
      4. group Id
        OG003
        lower Limit
        4.80
        upper Limit
        7.39
        value
        5.7
denoms
  1. counts
    1. group Id
      OG000
      value
      319
    2. group Id
      OG001
      value
      302
    3. group Id
      OG002
      value
      132
    4. group Id
      OG003
      value
      323
    units
    Participants
description
European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.
dispersion Type
95% Confidence Interval
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 the FAS who had baseline scores of \>=10. T75+D arm was closed during study.
reporting Status
POSTED
time Frame
At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
title
EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice