Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models (NCT06463444) | Clinical Trial Compass
RecruitingPhase 1
Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models
China30 participantsStarted 2024-06-01
Plain-language summary
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 monoclonal antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 18-75.
✓. No previous local or systemic treatment for hepatocellular carcinoma.
✓. Child-Pugh liver function score ≤ 7.
✓. ECOG PS 0-1.
✓. No serious organic diseases of the heart, lungs, brain, kidneys, etc.
✓. Enhanced MRI determines that the tumor is technically unresectable.
✓. Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy.
✓. Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors.
Exclusion criteria
✕. Pregnant and lactating women.
✕. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
✕. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
What they're measuring
1
Objective response rate
Timeframe: From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 months.