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
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 the rate of subjects with major pathological response for phase 2 study and event-free survival (EFS) by investigator for phase 3 study of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate EFS by Blinded Independent Review Committee, the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, overall survival and disease-free survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Volunteer to participate in this study and sign an informed consent form
2. Age 18\~75 years old, no gender limit
3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging
4. CNLC stage Ib/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus
5. Child-Pugh score: A grade (≤6 points)
6. ECOG PS score: 0-1 points
Exclusion Criteria:
1. 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.
2. Currently accompanied by interstitial pneumonia or interstitial lung disease
3. Existence of active autoimmune disease or history of autoimmune disease and may relapse
4. Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count \>15\*10\^9/L
5. Patients with congenital or acquired immune deficiencies (such as HIV-infected persons)
6. Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients
Primary outcome measure(s)
Event-free survival (EFS) assessed by investigator — up to 3 years The primary endpoint of phase 3 study is EFS assessed by investigator, which 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.
The rate of subjects of major pathological response (MPR) — From enrollment to 30 days post-surgery The primary endpoint of phase 2 study is the rate of subjects of MPR in the first 60 patients in the experimental group. MPR is defined as less than or equal to 50% residual tumor after neoadjuvant therapy of camrelizumab and apatinib therapy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.