Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma
Recruiting now · Phase 3
Conditions studied: Hepatocellular Carcinoma, Immunotherapy, Preoperative
In brief
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.
Key facts
- Study ID
- NCT05613478
- Run by
- The First Affiliated Hospital with Nanjing Medical University
- People needed
- 130
- Starts
- 2023-01-31
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2024-12-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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