Participant flow

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.

groups

1. description

   Durvalumab 1500 mg every 4 weeks (Q4W)

   id

   FG000

   title

   Durva 1500 mg

2. description

   Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W

   id

   FG001

   title

   Treme 300 mg x1 Dose + Durva 1500 mg

3. description

   Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W

   id

   FG002

   title

   Treme 75 mg x4 Doses + Durva 1500 mg

4. description

   Sorafenib 400 mg twice daily (BID)

   id

   FG003

   title

   Sora 400 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         275

      2. group Id

         FG001

         num Subjects

         260

      3. group Id

         FG002

         num Subjects

         122

      4. group Id

         FG003

         num Subjects

         280

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         7

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         20

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         389

      2. group Id

         FG001

         num Subjects

         393

      3. group Id

         FG002

         num Subjects

         153

      4. group Id

         FG003

         num Subjects

         389

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         386

      2. group Id

         FG001

         num Subjects

         389

      3. group Id

         FG002

         num Subjects

         153

      4. group Id

         FG003

         num Subjects

         374

      comment

      One participant in T300+D and one in T75+D arm didn't receive Treme and were analyzed under the Durva mono arm in the safety analysis set

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         125

      3. group Id

         FG002

         num Subjects

         30

      4. group Id

         FG003

         num Subjects

         82

      comment

      Completed final analysis and ongoing in long-term follow-up

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         285

      2. group Id

         FG001

         num Subjects

         268

      3. group Id

         FG002

         num Subjects

         123

      4. group Id

         FG003

         num Subjects

         307

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of 1,950 participants screened in the study, 1,324 were randomized across 4 arms, out of which 1,302 participants received treatment.

recruitment Details

The study includes 1324 participants. Participants were screened in 16 countries from Oct2017 to Jun2019. Recruitment in T75+D arm was closed during the study. Results are reported at data cut-off (DCO).

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

Preserved source evidence · Not medical advice