Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChen Xiaoping
About this trial
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%.
Eligibility criteria
Qualifiers
Aged 18-75.
No previous local or systemic treatment for hepatocellular carcinoma.
Child-Pugh liver function score ≤ 7.
ECOG PS 0-1.
Disqualifiers
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.
Active infection.
Trial design
Treatments tested in this trial
- HAIC + Tislelizumab +lenvatinib
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Chen Xiaoping
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov