Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma
Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma: a Randomized, Open-label, Parallel, Multicenter Trial
The First Affiliated Hospital with Nanjing Medical University
130 participants
Jan 31, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
- Child-Pugh score: A grade (≤6 points).
- ECOG PS score: 0-1 points.
Exclusion Criteria6
- 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.
- Patients with congenital or acquired immune deficiencies (such as HIV-infected persons).
- Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients.
Interventions
Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery
Radical surgery
TACE treatment before preoperative camrelizumab combined with apatinib mesylate
Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05613478