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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: Clinical Trial Phase 2 study, sponsored by Mehmet Akce.
NCT06855225 is a Phase 2 study that has not yet begun recruiting, run by Mehmet Akce. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST version 1.1. A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
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 |
What is known before NCT06855225 opens enrollment
NCT06855225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT06855225 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06855225's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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