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NCT03298451 · OUTCOME

EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) 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

EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase 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 have a baseline symptom score \<= 90. 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 mg308
Treme 300 mg x1 Dose + Durva 1500 mg288
Treme 75 mg x4 Doses + Durva 1500 mg127
Sora 400 mg309

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durva 1500 mg16.0Not reported9.0322.31Not reported
Treme 300 mg x1 Dose + Durva 1500 mg12.6Not reported9.2319.58Not reported
Treme 75 mg x4 Doses + Durva 1500 mg13.8Not reported6.4719.19Not reported
Sora 400 mg9.4Not reported7.4613.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.03
        upper Limit
        22.31
        value
        16.0
      2. group Id
        OG001
        lower Limit
        9.23
        upper Limit
        19.58
        value
        12.6
      3. group Id
        OG002
        lower Limit
        6.47
        upper Limit
        19.19
        value
        13.8
      4. group Id
        OG003
        lower Limit
        7.46
        upper Limit
        13.37
        value
        9.4
denoms
  1. counts
    1. group Id
      OG000
      value
      308
    2. group Id
      OG001
      value
      288
    3. group Id
      OG002
      value
      127
    4. group Id
      OG003
      value
      309
    units
    Participants
description
EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase 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 have a baseline symptom score \<= 90. 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-HCC18 Time to Symptom (Shoulder Pain) Deterioration
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice