RecruitingPhase 2NCT06420440

Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model

Efficacy and Safety of Neoadjuvant HAIC Combined With Tislelizumab and Lenvatinib in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model: a Multicenter Randomized Controlled Trial.

Sponsor

Chen Xiaoping

Enrollment

160 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

HCC

Summary

Primary liver cancer is one of the most common malignant tumors in the world, and about 80%\~90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). Radical surgery is the main method for patients with HCC to obtain long-term survival. However, the early recurrence rate of high-risk HCC is very high, which seriously affects the overall therapeutic effect.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of treatments — including liver-directed chemotherapy (HAIC), a targeted drug (lenvatinib), and an immunotherapy drug — as a pre-surgery treatment for liver cancer (hepatocellular carcinoma, or HCC). An AI model identifies which patients are most likely to benefit from this approach. **You may be eligible if...** - You are aged 18–75 with confirmed liver cancer (HCC) - You have not received any prior treatment for HCC - Your liver is functioning well enough (Child-Pugh score ≤ 7) - Your tumor can potentially be removed surgically but is high-risk for recurrence - An AI deep learning model predicts you would benefit from this treatment combination **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have cancer that has spread to distant organs (beyond what is resectable) - You have serious heart, lung, brain, or kidney disease 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

PROCEDUREHepatic arterial infusion chemotherapy

Patients in the neoadjuvant group received two cycles of neoadjuvant hepatic arterial infusion chemotherapy (HAIC, adoption of the FOFOLX6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days)

DRUGLenvatinib

Patients in the neoadjuvant therapy group received Lenvatinib before surgery(Len was started before HAIC treatment, discontinued during HAIC treatment, and discontinued approximately two weeks before surgery, Oral 8 mg or 12mg once a day depending body weight).

DRUGTislelizumab

Patients in the neoadjuvant therapy group received two cycles of Tislelizumab therapy before surgery (First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)

PROCEDURELiver resection

Patients in the neoadjuvant therapy group were evaluated for tumor status and surgical safety after neoadjuvant therapy, and eligible patients subsequently underwent surgical resection. Patients in the direct surgery group underwent liver resection.

DRUGTislelizumab

Given the high risk of postoperative recurrence, patients in both groups received adjuvant Tis therapy (every 21 days for 8 cycles) starting about one month after surgery.

Locations(2)

Huapeng Sun

Xiangyang, Hubei, China

Enyu Liu

Jinan, Shandong, China

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NCT06420440

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