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NCT03298451 · OUTCOME

Disease Control Rate (DCR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

What was measured

Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. 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. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.

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

Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Durva 1500 mg213Not reportedNot reportedNot reportedNot reported
Treme 300 mg x1 Dose + Durva 1500 mg236Not reportedNot reportedNot reportedNot reported
Treme 75 mg x4 Doses + Durva 1500 mg89Not reportedNot reportedNot reportedNot reported
Sora 400 mg236Not reportedNot reportedNot reportedNot reported
No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Durva 1500 mg176Not reportedNot reportedNot reportedNot reported
Treme 300 mg x1 Dose + Durva 1500 mg157Not reportedNot reportedNot reportedNot reported
Treme 75 mg x4 Doses + Durva 1500 mg64Not reportedNot reportedNot reportedNot reported
Sora 400 mg153Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        213
      2. group Id
        OG001
        value
        236
      3. group Id
        OG002
        value
        89
      4. group Id
        OG003
        value
        236
    title
    Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        176
      2. group Id
        OG001
        value
        157
      3. group Id
        OG002
        value
        64
      4. group Id
        OG003
        value
        153
    title
    No
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
Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. 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. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.
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
COUNT_OF_PARTICIPANTS
population Description
The FAS included all participants who were randomized. T75+D arm was closed during study.
reporting Status
POSTED
time Frame
From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
title
Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice