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Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model.
Sponsor: Chen Xiaoping
Summary
Primary liver cancer is one of the most common malignant tumors in the world, and more than 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). The intermediate stage (BCLC-B) HCC is highly heterogeneous, and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries. New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate.
Official title: Efficacy and Safety of Neoadjuvant HAIC Combined With Immunotherapy and Targeted Therapy in Patients With Resectable Intermediate-stage HCC Screened by a Multimodal Deep Learning Model: a Multicenter Randomized Controlled Trial.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2024-05-01
Completion Date
2028-12-31
Last Updated
2024-03-15
Healthy Volunteers
No
Conditions
Interventions
HAIC + Tirelizumab +lenvatinib +liver resection
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) + Tirelizumab (First treatment with Tirelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)+ lenvatinib (Oral 8 mg or 12mg once a day depending body weight). Assessment of tumor status and surgical safety after receiving neoadjuvant therapy, and eligible patients then underwent surgical resection.
liver resection
Direct liver resection or laparoscopic liver resection depending on tumor status.