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NCT05194293 · ClinicalTrials.gov registry record · Phase 2
Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer
A Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IIIA Hepatocellular Carcinoma AJCC V8, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
- 3
- Study locations
NCT05194293: Active Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IIIA Hepatocellular Carcinoma AJCC V8, sponsored by Academic and Community Cancer Research United.
NCT05194293 is a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IIIA Hepatocellular Carcinoma AJCC V8 that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 4 participants, below the 60-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05194293, a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IIIA Hepatocellular Carcinoma AJCC V8, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial tests whether regorafenib and durvalumab work to shrink tumors in patients with high-risk liver cancer. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and durvalumab may work better in treating patients with high-risk liver cancer.
Primary Outcome
An objective response is defined as a complete response (CR) or partial response (PR). Disease status will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 criteria. ORR is defined as the proportion of evaluable patient who experience a CR or PR divided by the total number of evaluable patients. The final ORR point estimate and corresponding 95% confidence interval will be reported.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- DRUG Regorafenib
Study Locations (3)
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2028-12-05 |
| Phase | Phase 2 |
What the registry record for NCT05194293 still lists
NCT05194293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT05194293 reports a single indexed study location in Alabama, Georgia, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05194293 about?
NCT05194293 is a clinical study titled "Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer". This phase II trial tests whether regorafenib and durvalumab work to shrink tumors in patients with high-risk liver cancer. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help th...
What is the current status of trial NCT05194293?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2023-07-01. Estimated completion is 2028-12-05.
What conditions does trial NCT05194293 study?
This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC V8, Stage IB Hepatocellular Carcinoma AJCC v8, Stage II Hepatocellular Carcinoma AJCC v8.
What interventions are being tested in trial NCT05194293?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Regorafenib (DRUG).
Who is sponsoring clinical trial NCT05194293?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05194293 being conducted?
This trial has 3 study locations across Alabama, Georgia, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Hepatocellular Carcinoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05194293's enrollment target sits among peer trials
4 15th of 14 the lowest of 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Hepatocellular Carcinoma AJCC v8 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.
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