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NCT06855225

A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 11 versions: 11 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Oct 2026 to Nov 2026
  2. Eligibility criteria expanded, about 60 words
    • Secondary endpoints: details revised at 2 of 4 entries
  3. Start date: Jul 2026 to Oct 2026v9
  4. Start date: May 2026 to Jul 2026v8
  5. Primary completion pushed from Apr 2026 to May 2027
    • Start date: Mar 2026 to May 2026
    • Study completion pushed from Apr 2027 to May 2028
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Dec 2025 to Mar 2026v6
  2. Start date: Sep 2025 to Dec 2025
    • Study sites: 0 to 1
    v5
  3. Start date: Jun 2025 to Sep 2025v4
  4. Study Identification, Study Status, Contacts/Locationsv3
  5. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Confirmed objective response rate (ORR)
Timeframe: 24 months

Secondary (4)

Overall Survival (OS)
Progression-free survival (PFS)
Disease control rate (DCR)
Adverse Event Rates

Arms and interventions

Single Tremelimumab with Regular Interval Durvalumab plus Gemcitabine and CisplatinExperimental

Cycles 1 through 8 will be in 3-week intervals and Cycles 9+ will be in 4-week intervals. Tremelimumab is administered at 300mg intravenously once at Cycle 1. Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+. Gemcitabine is administered at 1000mg/m\^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Cisplatin is administered at 25mg/m\^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only.

Drugs: Tremelimumab, Durvalumab, Gemcitabine, Cisplatin

Sites

1 site in 1 country

  • University of Alabama at BirminghamBirmingham, Alabama, United States