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NCT03298451 · OUTCOME

Overall Survival (OS) at 18, 24, and 36 Months After Randomization

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
NUMBER
Unit
percentage of survival
Interval / dispersion
95% Confidence Interval
Time frame
At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).

What was measured

Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.

Analysis population: The FAS included all participants who were randomized. 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 mg389
Treme 300 mg x1 Dose + Durva 1500 mg393
Treme 75 mg x4 Doses + Durva 1500 mg153
Sora 400 mg389

Reported measurements

Survival rate at 18 months
Values in percentage of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durva 1500 mg47.4Not reported42.452.3Not reported
Treme 300 mg x1 Dose + Durva 1500 mg48.7Not reported43.653.5Not reported
Treme 75 mg x4 Doses + Durva 1500 mg46.4Not reported38.454.1Not reported
Sora 400 mg41.5Not reported36.546.4Not reported
Survival rate at 24 months
Values in percentage of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durva 1500 mg39.6Not reported34.844.5Not reported
Treme 300 mg x1 Dose + Durva 1500 mg40.5Not reported35.645.3Not reported
Treme 75 mg x4 Doses + Durva 1500 mg37.3Not reported29.644.9Not reported
Sora 400 mg32.6Not reported27.937.4Not reported
Survival rate at 36 months
Values in percentage of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durva 1500 mg24.7Not reported20.029.8Not reported
Treme 300 mg x1 Dose + Durva 1500 mg30.7Not reported25.835.7Not reported
Treme 75 mg x4 Doses + Durva 1500 mg22.9Not reported16.629.8Not reported
Sora 400 mg20.2Not reported15.825.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.4
        upper Limit
        52.3
        value
        47.4
      2. group Id
        OG001
        lower Limit
        43.6
        upper Limit
        53.5
        value
        48.7
      3. group Id
        OG002
        lower Limit
        38.4
        upper Limit
        54.1
        value
        46.4
      4. group Id
        OG003
        lower Limit
        36.5
        upper Limit
        46.4
        value
        41.5
    title
    Survival rate at 18 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.8
        upper Limit
        44.5
        value
        39.6
      2. group Id
        OG001
        lower Limit
        35.6
        upper Limit
        45.3
        value
        40.5
      3. group Id
        OG002
        lower Limit
        29.6
        upper Limit
        44.9
        value
        37.3
      4. group Id
        OG003
        lower Limit
        27.9
        upper Limit
        37.4
        value
        32.6
    title
    Survival rate at 24 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        29.8
        value
        24.7
      2. group Id
        OG001
        lower Limit
        25.8
        upper Limit
        35.7
        value
        30.7
      3. group Id
        OG002
        lower Limit
        16.6
        upper Limit
        29.8
        value
        22.9
      4. group Id
        OG003
        lower Limit
        15.8
        upper Limit
        25.1
        value
        20.2
    title
    Survival rate at 36 months
denoms
  1. counts
    1. group Id
      OG000
      value
      389
    2. group Id
      OG001
      value
      393
    3. group Id
      OG002
      value
      153
    4. group Id
      OG003
      value
      389
    units
    Participants
description
Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.
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
NUMBER
population Description
The FAS included all participants who were randomized. T75+D arm was closed during study.
reporting Status
POSTED
time Frame
At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).
title
Overall Survival (OS) at 18, 24, and 36 Months After Randomization
type
SECONDARY
unit Of Measure
percentage of survival

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

Preserved source evidence · Not medical advice