Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Camrelizumab: Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery

Apatinib Mesylate: Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery

Radical surgery: Radical surgery

Preoperative TACE treatment: TACE treatment before preoperative camrelizumab combined with apatinib mesylate

Camrelizumab: Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery

Apatinib Mesylate: Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery

Study summary

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.

Eligibility

Primary outcome measure(s)

• 2 year event-free survival（2y-EFS） — 2-year
  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.

Trial sites (1)

More The First Affiliated Hospital with Nanjing Medical University trials in China

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