HAIC Combined With Second-line "Target Immunity" for HCC With TACE Standard Treatment Low Response or Failure

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, randomized controlled, multicenter clinical study. The purpose of this study is to explore the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with second-line regorafenib and immune checkpoint inhibitors in the treatment of transarterial chemoembolization (TACE) combined with first-line molecular targeted drugs and immune checkpoint inhibitors with low response or failure in advanced hepatocellular carcinoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Central Hospital of Lishui City
• Treatments: Immune Checkpoint Inhibitors; Nivolumab; Pembrolizumab

Criteria

Inclusion Criteria:

• Voluntarily participate in this study and sign the informed consent;

• Age ≥18 years old to 70 years old;

• Patients diagnosed with primary liver cancer by histopathology, cytology or imaging;

• The China liver cancer staging is IIb-IIIa;

• Patients with intermediate and advanced liver cancer who must receive at least one cycle of TACE combined with first-line "target immune" therapy and are assessed as partial remission (PR), stable disease (SD）(low response), and progressive disease (PD) (failure) according to mRECIST criteria;

• At least one measurable (based on RECIST 1.1 criteria and mRECIST criteria) lesions, tumor lesions located at the local treatment site, if progressed, considered measurable;

• Local treatment (surgery, radiotherapy, radiofrequency/microwave ablation, cryoablation, percutaneous ethanol injection) can be used in the past, but it must be completed before 3 months;

• ECOG PS score ≤ 2;

• Child-Pugh liver function classification: grade A/B (≤9 points);

• Expected survival > 3 months;

• Patients with active hepatitis B virus (HBV) infection: HBV DNA ≤2000 IU/mL (104 cps/ml) obtained within 28 days prior to initiation of study treatment, and receiving anti-HBV treatment for at least 14 days prior to study entry (based on local standard treatment) and willing to continue to receive treatment during the study;

Exclusion Criteria:

• Have received HAIC treatment in the past;

• Known allergy to possible therapeutic drugs;

• Previously received regorafenib treatment;

• According to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0), the toxicity grade caused by TACE combined with first-line "target immunity" treatment is > grade 3;

• Patients with liver decompensation, including esophageal or gastric variceal bleeding or hepatic encephalopathy, pregnancy or breastfeeding and other aggressive malignant diseases;

• Use immunosuppressive drugs and high-dose hormone therapy within 2 weeks before randomization to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other hormones with equivalent efficacy);

• CART treatment within 3 months before randomization;

• Laboratory test values 1 week before randomization: blood routine: ① leukocyte <3.0×109/L; ② absolute neutrophil count <1.5×109/L; ③ platelets <75×109/L; ④ hemoglobin < 90g/L; liver function: ①serum albumin<30g/L; ②ALT and AST>5×ULN; renal function: ①serum creatinine>1.5×ULN; ②Cr clearance rate<50ml/min; ③estimated renal small Globular filtration rate (eGFR) <30 mL/min/1.73 m2; coagulation function: ① international normalized ratio (INR)> 2; ② prothrombin time (PT) exceeding the range of normal control> 6 seconds;

• Uncontrolled hypertension (systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg);

• Uncontrollable diabetes;

• Active heart disease, including myocardial infarction, unstable angina pectoris, NYHA class II and above heart failure, and poorly controlled arrhythmias (including QTcF interval >450 ms in men and >470 ms in women);

• Women are pregnant or breastfeeding;

• History of any active autoimmune disease or autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, vasculitis, glomerulonephritis, hyperthyroidism, or hypothyroidism, asthma requiring bronchodilator treatment, etc;

• Uncontrolled clinically significant ascites (uncontrolled with diuretics or paracentesis);

• Combined with active infection, except HBV and HCV;

• Arterial or venous thrombosis or embolic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis or pulmonary embolism, occurred 6 months before starting drug treatment;

• Known central nervous system (CNS) metastasis or meningeal metastasis;

• The patient cannot receive follow-up or is participating in other clinical trials;

• The investigator believes that the patient has other conditions that make it inappropriate to participate in this study.