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Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

Study acronym: ACTICCA-1
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 30, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Apr 2024 to Dec 2025
    • Site details revised at 4 of 67 sites
    v21
  2. Primary completion date: Apr 2023 to Apr 2024v20
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 781 to confirmed 789
    • Study sites: 66 to 67
    v19
  4. Primary completion date: Apr 2022 to Apr 2023
    • Study sites: 63 to 66
    • Eligibility criteria shortened, about 21 words
    • Study description shortened, about 38 words
    v18
  5. Primary completion date: Apr 2021 to Apr 2022
    • Study sites: 61 to 63
    • Study completion date: Apr 2023 to Apr 2024
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 64 to 61
    • Eligibility criteria expanded, about 21 words
    • Study description expanded, about 32 words
    • Collaborators revised (4)
    v16
  2. Study sites revised (64)
    • Collaborators: 5 to 4
    v15
  3. Primary completion date: Apr 2019 to Apr 2021
    • Study sites: 63 to 64
    • Study completion date: Apr 2022 to Apr 2023
    v14
  4. Site details revised at 3 of 63 sites
    • Collaborators revised (5)
    v13
  5. Site details revised at 22 of 63 sitesv12
  6. Study sites: 62 to 63
    • Collaborators revised (5)
    v11
  7. Study description expanded, about 10 wordsv10
  8. Enrollment target: 440 to 781v9 Show 6 more changesShow less
    • Interventions: Cisplatin (Drug), Gemcitabine (Drug), Observation (Other) to Capecitabine (Drug), Cisplatin (Drug), Gemcitabine (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 169 words
    • Site details revised at 4 of 62 sites
    • Study title expanded, about 2 words
  9. Study sites: 61 to 62v8
  10. Study sites: 51 to 61v7
  11. Collaborators: 2 to 5v6
  12. Site details revised at 6 of 51 sitesv5
  13. Study sites: 46 to 51v4
  14. Study sites: 24 to 46
    • Eligibility criteria revised
    v3
  15. Enrollment target: 450 to 440
    • Study sites: 22 to 24
    • Study description expanded, about 170 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.
Trial Details
NCT Number NCT02170090
Lead Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany), Cancer Research UK, Australasian Gastro-Intestinal Trials Group, Dutch Cancer Society
Conditions
(from sponsor)		 Cholangiocarcinoma, Gall Bladder Carcinoma
Related terms Cholangiocarcinoma, Gallbladder Neoplasms
Enrollment 789 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov