Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC): A Randomized, Controlled, Open-Label, Multicenter Phase III.
This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).
• Patients volunteered to participate in this study and signed informed consent;
• ≥18 years old, male and female;
• Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);
• BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.
• Local therapy (including but not limited to surgery, radiation therapy, transarterial chemoembolization \[TACE\], hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks prior to the baseline radiographic scan (with the exception of palliative radiotherapy, for which a 2-week interval is sufficient).
• Has not received any systemic treatment for HCC.
• According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
• Child-pugh liver function grading: Grade A or Grade Better B (≤7 points)
• ECOG PS score 0-2;
⁃ Expected survival ≥ 12 weeks;
⁃ Major organ functions are basically normal and meet the following requirements (within 7 days before starting the study treatment):
∙ Complete blood count: absolute neutrophil count ≥ 1.5\*10\^9/L, platelets (PLT) ≥ 75\*10\^9/L, hemoglobin ≥ 90 g/L;
‣ Blood biochemistry: albumin ≥ 25 g/L; total bilirubin ≤ 3.0 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 5 × ULN; creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCl) \> 50 mL/min.
‣ International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) no more than 6 seconds above the normal control range;
‣ Urine protein \<2 (if urine protein ≥2, a 24-hour urine protein quantification can be performed; 24-hour urine protein \<1.0 g is allowed for inclusion).
⁃ Patients with active hepatitis B virus (HBV) infection must receive anti-HBV therapy prior to initiating study treatment and be willing to continue antiviral therapy throughout the study; hepatitis C virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines with liver function not exceeding CTCAE grade 1 elevation.
⁃ Women of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to study enrollment, must not be breastfeeding, and must agree to use contraception during the study and for 6 months after the study; men must agree to use contraception during the study and for 6 months after the study.
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