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NCT05168163 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
A Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Academic and Community Cancer Research United.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
- 16
- Study locations
NCT05168163: Recruiting Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Academic and Community Cancer Research United.
NCT05168163 is a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8 that is actively recruiting participants, run by Academic and Community Cancer Research United. The registered enrollment target is 122 participants, above the 51-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (139% higher). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05168163, a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, is actively recruiting participants, sponsored by Academic and Community Cancer Research United.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
- 16
- Study locations
Study Summary
This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.
Primary Outcome
The final analysis for OS will be conducted when 84 OS events are observed, approximately 36 months after first subject in and will be evaluated with a one-sided p-value from stratified log-rank test.
Conditions Studied
Interventions
- BIOLOGICAL Atezolizumab
- DRUG Cabozantinib
- DRUG Lenvatinib
Study Locations (16)
Florida
- Mayo Clinic in Florida - Jacksonville
- Cleveland Clinic Weston Florida - Weston
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- Carle Cancer Center NCI Community Oncology Research Program - Urbana
Michigan
- Michigan Cancer Research Consortium NCORP - Ann Arbor
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Wisconsin
- Froedtert and the Medical College of Wisconsin LAPS - Milwaukee
- Medical College of Wisconsin - Milwaukee
Arizona
- Mayo Clinic in Arizona - Scottsdale
Louisiana
- University Medical Center New Orleans - New Orleans
Minnesota
- Mayo Clinic in Rochester - Rochester
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2022-05-27 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT05168163 shows while recruiting
NCT05168163 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 51-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (139% higher).
The record links to 9 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT05168163 lists 16 locations in 12 states (Florida, Illinois, Michigan).
Frequently Asked Questions
What is clinical trial NCT05168163 about?
NCT05168163 is a clinical study titled "Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer". This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymp...
What is the current status of trial NCT05168163?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2022-05-27. Estimated completion is 2026-12-31.
What conditions does trial NCT05168163 study?
This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma, Stage IIIA Hepatocellular Carcinoma AJCC V8.
What interventions are being tested in trial NCT05168163?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), Cabozantinib (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT05168163?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05168163 being conducted?
This trial has 16 study locations across Arizona, Florida, Illinois, Louisiana, Michigan. 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 NCT05168163's enrollment target sits among peer trials
122 2nd of 14 the highest 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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