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.
Aged 18-75.
No previous local or systemic treatment for hepatocellular carcinoma.
Child-Pugh liver function score ≤ 7.
ECOG PS 0-1.
Pregnant and lactating women.
Tumor distribution in two liver lobes, diffuse growth, or other reasons why radical R0 resection is not possible.
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.
Parallel
HAIC + Tirelizumab +lenvatinib +liver resection
DrugPatients 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
Procedure/SurgeryDirect liver resection or laparoscopic liver resection depending on tumor status.
Disease-free survival
DFS defined as the time after surgical resection until tumor recurrence or death
Safety Assessment
Any adverse event during treatment that is incompatible with the therapeutic purpose of the medication.
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Chen Xiaoping
Lead sponsor
Tongji Hospital
Sponsor institution
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