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NCT06811116 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial
A Phase 1 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
- 4
- Study locations
NCT06811116: Recruiting Phase 1 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT06811116 is a Phase 1 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 92 participants, above the 82-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (12% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06811116, a Phase 1 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (change) in the β-catenin gene. Sapanisertib and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sapanisertib and cabozantinib together may work better than giving cabozantinib alone in treating β-catenin-mutated metastatic hepatocellular carcinoma.
Primary Outcome
Dose limiting toxicities and adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be tabulated for each dose level.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Cabozantinib S-malate
- PROCEDURE Imaging Procedure
- DRUG Sapanisertib
Study Locations (4)
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Oregon
- Oregon Health and Science University - Portland
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2025-11-17 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 1 |
What NCT06811116 shows while recruiting
NCT06811116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 82-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (12% higher).
The record links to 4 conditions, with Advanced Hepatocellular Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT06811116 reports a single indexed study location in California, Oregon, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06811116 about?
NCT06811116 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial". This phase I/II trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (chang...
What is the current status of trial NCT06811116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2025-11-17. Estimated completion is 2027-08-31.
What conditions does trial NCT06811116 study?
This clinical trial studies the following conditions: Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Metastatic Hepatocellular Carcinoma.
What interventions are being tested in trial NCT06811116?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Cabozantinib S-malate (DRUG), Imaging Procedure (PROCEDURE), Sapanisertib (DRUG).
Who is sponsoring clinical trial NCT06811116?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06811116 being conducted?
This trial has 4 study locations across California, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06811116's enrollment target sits among peer trials
92 7th of 16 higher than 10 of 16 other Advanced Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Hepatocellular Carcinoma 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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