RecruitingPhase 1NCT06463444

Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models

Precision Treatment of Unresectable Liver Cancer Based on Multi-omics Deep Learning Model: a Multi-center Prospective Single-arm Study

Sponsor

Chen Xiaoping

Enrollment

30 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

HCC Precision Therapy

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%.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

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 Criteria6

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.
Other significant clinical and laboratory abnormalities that affect the safety evaluation.
Inability to follow the study protocol for treatment or follow up as scheduled.

Interventions

DRUGHAIC + Tislelizumab +lenvatinib

All patients were treated with HAIC combined with tislelizumab and lenvatinib. 1. HAIC was adopted of the FOFOLX 6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days. 2. Lenvatinib was started before HAIC treatment, discontinued during HAIC treatment, Oral 8 mg or 12mg once a day depending body weight. 3. First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later.