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

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

Plain Language Summary

Simplified for easier understanding

This trial tests whether a precision treatment approach guided by AI deep-learning models — analyzing a patient's tumor tissue, imaging, and genetic data — can better match people with unresectable liver cancer (HCC) to a combination treatment of HAIC chemotherapy, lenvatinib (a targeted drug), and a PD-1 immunotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have hepatocellular carcinoma confirmed by biopsy that cannot be surgically removed - You have not previously received any treatment for your liver cancer - Your liver function is reasonably preserved (Child-Pugh ≤7, ECOG 0–1) - The AI model suggests you are likely to benefit from HAIC plus combination treatment **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had gastrointestinal bleeding in the past 4 weeks or have high bleeding risk - You have an active infection - You have serious organ conditions affecting drug absorption or clearance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06463444


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