Perioperative Sintilimab Plus Bevacizumab Biosimilar and Transarterial Embolization, Hepatic Artery Infusion Chemotherapy (TACE-HAIC) for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus (PVTT): A Phase-2 Clinical Trial
Although resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients. We initialed this phase 2 clinical trial to prove the perioperative therapy.
• Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements);
• Child-Pugh score ≤ 6 points (Child-Pugh A);
• BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤ 10cm of primary liver cancer.
• Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
• ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
• Expected survival period ≥ 12 weeks;
• The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration):