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NCT03298451 · OUTCOME

Overall Survival (OS) by PD-L1

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
From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

What was measured

Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP \< 1%).

Analysis population: A subset of FAS who had non-missing baseline PD-L1 status. 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 mg344
Treme 300 mg x1 Dose + Durva 1500 mg337
Treme 75 mg x4 Doses + Durva 1500 mg144
Sora 400 mg329

Reported measurements

PD-L1 expression positive (TIP>=1%)

Analysis denominator · Participants

GroupSource count
Durva 1500 mg154
Treme 300 mg x1 Dose + Durva 1500 mg148
Treme 75 mg x4 Doses + Durva 1500 mg65
Sora 400 mg148
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durva 1500 mg17.22Not reported12.2924.38Not reported
Treme 300 mg x1 Dose + Durva 1500 mg17.00Not reported13.1122.31Not reported
Treme 75 mg x4 Doses + Durva 1500 mg24.21Not reported14.5527.24Not reported
Sora 400 mg15.93Not reported10.6821.72Not reported
PD-L1 expression negative (TIP<1%)

Analysis denominator · Participants

GroupSource count
Durva 1500 mg190
Treme 300 mg x1 Dose + Durva 1500 mg189
Treme 75 mg x4 Doses + Durva 1500 mg79
Sora 400 mg181
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durva 1500 mg15.06Not reported12.6818.53Not reported
Treme 300 mg x1 Dose + Durva 1500 mg14.26Not reported11.5021.29Not reported
Treme 75 mg x4 Doses + Durva 1500 mg14.46Not reported8.9717.51Not reported
Sora 400 mg13.93Not reported12.3916.69Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.29
        upper Limit
        24.38
        value
        17.22
      2. group Id
        OG001
        lower Limit
        13.11
        upper Limit
        22.31
        value
        17.00
      3. group Id
        OG002
        lower Limit
        14.55
        upper Limit
        27.24
        value
        24.21
      4. group Id
        OG003
        lower Limit
        10.68
        upper Limit
        21.72
        value
        15.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        148
      3. group Id
        OG002
        value
        65
      4. group Id
        OG003
        value
        148
      units
      Participants
    title
    PD-L1 expression positive (TIP>=1%)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.68
        upper Limit
        18.53
        value
        15.06
      2. group Id
        OG001
        lower Limit
        11.50
        upper Limit
        21.29
        value
        14.26
      3. group Id
        OG002
        lower Limit
        8.97
        upper Limit
        17.51
        value
        14.46
      4. group Id
        OG003
        lower Limit
        12.39
        upper Limit
        16.69
        value
        13.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      2. group Id
        OG001
        value
        189
      3. group Id
        OG002
        value
        79
      4. group Id
        OG003
        value
        181
      units
      Participants
    title
    PD-L1 expression negative (TIP<1%)
denoms
  1. counts
    1. group Id
      OG000
      value
      344
    2. group Id
      OG001
      value
      337
    3. group Id
      OG002
      value
      144
    4. group Id
      OG003
      value
      329
    units
    Participants
description
Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP \< 1%).
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 FAS who had non-missing baseline PD-L1 status. T75+D arm was closed during study.
reporting Status
POSTED
time Frame
From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
title
Overall Survival (OS) by PD-L1
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice