OncoMatch/Clinical Trials/NCT06811116
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
Is NCT06811116 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Cabozantinib S-malate and Sapanisertib for advanced hepatocellular carcinoma.
Treatment: Cabozantinib S-malate · Sapanisertib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: CTNNB1 mutation
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immune checkpoint inhibitor — metastatic
Cannot have received: cabozantinib
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,000/mcL; Platelets ≥ 30,000/mcL
Kidney function
Glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m^2
Liver function
Child Pugh score of A; Total bilirubin ≤ 1.5 × institutional ULN; AST/ALT ≤ 5 × institutional ULN
Cardiac function
NYHA class II or better
Child Pugh score of A; Absolute neutrophil count ≥ 1,000/mcL; Platelets ≥ 30,000/mcL; Total bilirubin ≤ 1.5 × institutional ULN; AST/ALT ≤ 5 × institutional ULN; Glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m^2; NYHA class II or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- Oregon Health and Science University · Portland, Oregon
- University of Pittsburgh Cancer Institute (UPCI) · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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