Participant flow

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) · Source last updated 2026-08-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

   id

   FG000

   title

   Durvalumab + Gemcitabine + Cisplatin

2. description

   Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

   id

   FG001

   title

   Placebo + Gemcitabine + Cisplatin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      type

      Ongoing study treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         8

      type

      Off treatment

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         308

      2. group Id

         FG001

         num Subjects

         326

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Re-consent refusal

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         341

      2. group Id

         FG001

         num Subjects

         344

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         338

      2. group Id

         FG001

         num Subjects

         342

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         341

      2. group Id

         FG001

         num Subjects

         344

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Eligible patients previously untreated for unresectable locally advanced or metastatic Biliary Tract Cancer (BTC) were randomized in a 1:1 ratio with either Durvalumab in combination with Gemcitabine/Cisplatin or Placebo in combination with Gemcitabine/Cisplatin. Randomization was stratified by disease status (initially unresectable versus recurrent) and primary tumor site (IHCC versus EHCC versus GBC).

recruitment Details

The study is active, not recruiting and conducted in 17 countries with 685 patients who were randomized prior to or on 18 December 2020. Results are reported for the study at data cut-off (DCO) 28 February 2025.

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Preserved source evidence · Not medical advice