Status:
UNKNOWN
HAIC Combined With Second-line "Target Immunity" for HCC With TACE Standard Treatment Low Response or Failure
Lead Sponsor:
The Central Hospital of Lishui City
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Detailed Description
This is a randomized, open, parallel-controlled, multi-center clinical trial with a type of comparison using a merit test. This study will recruit 176 patients with advanced liver cancer who have rece...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05233358
Start Date
February 1 2022
End Date
February 1 2025
Last Update
February 10 2022
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