Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma

Exclusion Criteria

• •Previous treatment with HAIC containing oxaliplatin;
• •Expected survival time less than 3 months
• •History of meningitis;
• •Current or past autoimmune diseases or immunodeficiency;
• •Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on screening computed tomography (CT) scan. Prior radiation pneumonitis in the radiation field (fibrosis) is allowed;
• •Known active tuberculosis;
• •Significant cardiovascular disease within 3 months prior to starting study treatment (e.g., New York Heart Association Class II or greater heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina;
• •History of congenital long QT syndrome or corrected QT interval \>500ms (calculated using Fridericia's method) at screening;
• •History of uncorrectable electrolyte disturbances such as serum potassium, calcium, or magnesium imbalances;
• •Major surgery within 4 weeks prior to starting study treatment (excluding diagnostic procedures) or anticipation of need for major surgical procedure during the course of the study;
• •History of malignancy other than HCC within 5 years prior to screening, unless the risk of recurrence or death from the previous malignancy is considered negligible (e.g., 5-year overall survival rate \>90%) and adequately treated in situ cervical cancer, non-melanoma skin cancer, localized prostate cancer, in situ ductal carcinoma, or stage I uterine cancer;
• •Severe infection within 4 weeks prior to starting study treatment, including but not limited to hospitalization for complications of infection, sepsis, or severe pneumonia;
• •Treatment with therapeutic antibiotics orally or intravenously within 2 weeks prior to starting study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease) are eligible for participation in the study;
• •Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
• •Receipt of attenuated live vaccines within 4 weeks prior to starting study treatment or anticipated need for such vaccines within 5 months after the last dose of PD-1 antibody therapy;
• •Untreated or incompletely treated esophageal and/or gastric varices associated with bleeding or patients at high risk of bleeding;
• •Concurrent HBV and HCV infection. Patients with a history of HCV infection but negative HCV RNA PCR results can be considered not infected with HCV;
• •Symptomatic, untreated, or gradually progressing central nervous system (CNS) metastases;
• •Inability to comply with follow-up or concurrent participation in another clinical trial that may interfere with this study;
• •The investigator deems the patient unsuitable for enrollment.