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NCT06855225 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
A Phase 2 study, sponsored by Mehmet Akce.
- Not yet
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT06855225 is a Phase 2 study that has not yet begun recruiting, run by Mehmet Akce. The registered enrollment target is 29 participants.
The verdict
NCT06855225, a Phase 2 study, has not yet begun recruiting, sponsored by Mehmet Akce.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). 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. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur at screening and then every 9 weeks until the end of Cycle 9. Disease assessments will then occur every 8 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months treatment from Cycle 1 Day 1 is allowed.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Durvalumab
- DRUG Tremelimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2026-07 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06855225
The ClinicalTrials.gov registry entry for NCT06855225 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mehmet Akce, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT06855225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06855225 about?
NCT06855225 is a clinical study titled "A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma". This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). Cycles 1 through 8 will be in 3 week intervals and Cycles 9+ ...
What is the current status of trial NCT06855225?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2026-07. Estimated completion is 2028-05.
What interventions are being tested in trial NCT06855225?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Durvalumab (DRUG), Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT06855225?
This trial is sponsored by Mehmet Akce, which has 2 total clinical trials registered on ClinicalTrials.gov.
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