Iparomlimab and Tuvonralimab (QL1706) With Bevacizumab and RALOX Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma (HCC) With Vp3/4 Portain Vein Thrombosis : A Prospective, Multicenter, Phase II Study
The goal of this prospective, single-arm, multi-center Phase II clinical trial is to evaluate the clinical efficacy and safety of QL1706 combined with bevacizumab and RALOX hepatic artery infusion chemotherapy in treating liver cancer patients with VP3/4 portal vein tumor thrombus. It will also explore molecular biomarkers that predict the efficacy of this combined therapy. The main questions it aims to answer are: What is the progression-free survival (PFS) of patients treated with this regimen? What are the objective response rate (ORR), disease control rate (DCR), and overall survival (OS) of these patients? What is the safety and tolerability profile of this combined treatment? Which molecular biomarkers can predict the efficacy of this therapy? Eligible subjects (who have signed informed consent) will receive RALOX hepatic artery infusion chemotherapy plus QL1706 (7.5mg, intravenous infusion every 3 weeks) and bevacizumab (15mg/kg, intravenous infusion every 3 weeks), with 3 weeks as one treatment cycle. Treatment will continue until a protocol-specified discontinuation event occurs. After treatment, subjects will undergo post-treatment safety follow-up and survival follow-up; those who discontinue treatment for reasons other than disease progression or death will also have tumor progression follow-up.
• Voluntarily sign the informed consent form;
• Aged ≥ 18 years, male and female subjects are both eligible;
• Clinically or pathologically confirmed hepatocellular carcinoma (HCC), with no prior systemic anti-tumor therapy for HCC (including but not limited to molecular targeted therapy, systemic chemotherapy, immunotherapy such as anti-PD-1/PD-L1/CTLA-4 monoclonal antibodies, etc.);
• Complicated with Type VP3 or VP4 portal vein tumor thrombosis (PVTT);
• Confirmed to have at least one measurable target lesion by imaging examination during the screening period in accordance with RECIST v1.1 criteria. The measurable lesions should not have received local treatment such as radiotherapy (lesions within the area of previous local treatment can also be selected as target lesions if disease progression is confirmed);
• Child-Pugh score ≤ 7 points (Child-Pugh class A-B);
• The maximum diameter of liver tumor ≥ 7 cm;
• ECOG performance status 0 to 1;
• Expected survival time ≥ 12 weeks;
⁃ Function of vital organs meeting the following requirements:
‣ Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count ≥ 50×10⁹/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 29 g/L; Bilirubin ≤ 2 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN, alkaline phosphatase (AKP) ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 50 mL/min calculated by the Cockcroft-Gault formula; 11.Eligible patients with reproductive potential (males and females) must agree to use a reliable contraceptive method (hormonal, barrier method or abstinence) with their partners during the trial and for at least 180 days after the last dose; female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first study medication administration.