Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Volunteer to participate in this study and sign an informed consent form.
Age ≥18 years old, no gender limit.
Hepatocellular carcinoma confirmed by histopathology, cytology or imaging.
CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with surgical excision combined with intraoperative ablation.
Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.
Currently accompanied by interstitial pneumonia or interstitial lung disease.
Existence of active autoimmune disease or history of autoimmune disease and may relapse.
Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count >15*10^9/L.
Parallel
Camrelizumab
DrugCamrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib Mesylate
DrugApatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery
Radical surgery
Procedure/SurgeryRadical surgery
Preoperative TACE treatment
Procedure/SurgeryTACE treatment before preoperative camrelizumab combined with apatinib mesylate
Camrelizumab
DrugCamrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib Mesylate
DrugApatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery
2 year event-free survival（2y-EFS）
2y-EFS is defined as time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
R0 resection rate
R0 resection rate
The rate of subjects of major pathological response (MPR)
MPR is defined as less than 10% residual tumor after neoadjuvant therapy of camrelizumab and apatinib therapy.
the rate of subjects with pathological complete response (pCR)
pCR is defined as no histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.
Overall survival (OS)
OS is defined as the time from randomisation to death.
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
