Hepatocellular Carcinoma
Conditions
Interventions
Treatment group:DEB-TACE+Adebrelimab+Apatinib
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years. 2. Hepatocellular carcinoma diagnosed by histology or cytology, or cirrhosis meets the clinical diagnostic criteria of hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD). 3. According to the "Chinese Primary Liver Cancer Diagnostic and Treatment Guidelines (2022 Edition)", those who meet the Chinese Liver Cancer Staging (CNLC) stage llla, lllb, or those who meet the Barcelona Clinic Liver Cancer (BCLC) stage C (with portal vein thrombosis) are not suitable for radical treatment, such as surgical resection, liver transplantation or ablation. 4. Have not received previous systemic antitumor therapy. 5. Suitable to receive TACE surgery and chemotherapeutic agents pre-specified by the study center without any contraindications. 6. At least one measurable lesion according to RECIST 1.1 or mRECIST evaluation criteria. 7. Agree to provide tissue samples for biomarker (e.g., PD-L1) analysis, preferably freshly obtained tissue, or 5-8 archival 3- to 5-µm thick paraffin sections for those who cannot provide freshly obtained tissue. 8. If the subject has HBV or HCV infection, the following criteria must be met. 1) HBV-infected subjects (HBsAg or HBV-DNA positive): should have received at least 3 days of guideline-recommended antiviral therapy prior to the first treatment and have had a decrease in HBV-DNA on retest, or have had HBVDNA of 2000 I/ml for 28 days prior to the first treatment, and must have continued to receive standardized antiviral therapy for the duration of the study; 2) HCV-infected subjects (HCVAb or HCV-RNA positive):in a stable state according to the investigator's judgment, and shall continue to receive antiviral therapy during the study period if they are receiving antiviral therapy. 9. Have adequate organ and bone marrow function as follows. 1) Blood count (corrective therapy with any blood component or cell growth factor, etc., is not permitted within the first 7 days of obtaining laboratory tests):Absolute neutrophil count (ANC) = 1.5x10°/L:Platelet count (PLT) = 75x10/LHemoglobin content (HGB) = 85g/L; 2)Liver function (albumin infusion not permitted within the first 7 days of obtaining laboratory tests):Serum total bilirubin (TBIL) = 2x upper limit of normal (ULN) or direct bilirubin = ULN for subjects with total bilirubin > 2x ULN:alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5x ULN:serum albumin = 28 g/L; 3) Renal function: serum creatinine (Cr) =1.5xULN, or calculated creatinine clearance (CCI) =50mL/min estimated according to the Cockeroft-Gault formula; routine urinalysis results show urinary protein <2+; routine urinalysis at baseline shows urinary protein =2+, should be performed a 24-hour urine collection and quantitatively <1g of urinary protein in a 24-hour period; and 4) Coagulation: International Normalized Ratio (INR) =2, or Activated Partial Thromboplastin Time (APTT) =1.5xULN. 10. Female subjects of childbearing potential must undergo a negative blood pregnancy test within 72 hours prior to the first administration of the drug (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, and the result of the serum pregnancy test shall prevail). 11. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception for the duration of the study and up to 120 days after
Exclusion criteria
Exclusion criteria: 1. Previous histologically/cytologically confirmed fibrolamellar carcinoma of liver, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components. 2. HCC foci =10 cm in any dimension, with more than 10 foci on imaging evaluation or foci occupying =70% of the liver volume. 3. Previous history of liver transplantation. 4. Previously received systemic anti-tumor therapy for hepatocellular carcinoma, including molecularly targeted drugs, systemic chemotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune checkpoint agonists, immune cells, etc.), and biologic therapy (e.g., tumor vaccines, cytokines, and cancer-control growth factors, etc.). 5. Previously received non-radical local treatment for liver lesions, such as TACE, transarterial embolization (TAE), transarterial radioembolization (TARE), hepatic artery infusion chemotherapy (HAIC), or radiation therapy. Subjects who received prophylactic TACE after radical treatment only once will be allowed to enroll in the study. 6. Received Chinese herbs or proprietary Chinese medicines with anti-tumor indications or drugs with immunomodulatory effects (including systemic use of thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first treatment. 7. Concurrent enrollment in another clinical study, unless it is a non-interventional clinical study or a follow-up period of an interventional study (defined as the time of the first dose being 4 weeks or more from the time of the last dose in the previous clinical study or 5 half-lives or more of the study drug, whichever is shorter). 8. Diagnosis of other malignancies within 3 years prior to first treatment, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ. 9. Severe bleeding tendency or coagulation disorder, or undergoing thrombolytic therapy. Within 10 days prior to the first treatment or under continuous treatment with non-steroidal anti-inflammatory drugs (e.g. indomethacin, ibuprofen, naproxen, etc.), antiplatelet drugs (e.g. clopidogrel, ticlopidine, dipyridamole, cilostazol, etc.) or anticoagulant drugs (e.g. warfarin, low molecular heparin, etc.). 10. Presence of inability to swallow the drug, malabsorption syndrome or any condition that interferes with the gastrointestinal absorption of Etan. 11. Systemic treatment with corticosteroids (prednisone >10mg/day or equivalent) or other immunosuppressive drugs within 2 weeks prior to the first treatment. The following are excluded. 1) epinephrine replacement corticosteroids ( prednisone < 10 mg/day or equivalent). 2)topical, ocular, intra-articular, intranasal or inhaled corticosteroids with minimal systemic absorption. 3) short-term use of corticosteroids to prevent hypersensitivity reactions (e.g., prophylaxis for computed tomography [CT] scans). 12. Known active tuberculosis (TB): Subjects suspected of having active TB should be excluded by clinical examination. 13. Known positive test for Human Immunodeficiency Virus (HIV) or known history of active Acquired Immune Deficiency Syndrome. 14. are pregnant or breastfeeding, or plan to breastfeed during the study period. 15. other acute or chronic medical condition, mental illness, or abnormal laboratory test values that could result in the following outcomes: increase the risk associated with the subject's participation in the study or receipt of study treatment, or interfere with the interpretation of the st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;Disease control rate;Duration of Response;Time to response;Progression-Free-Survival 2;Overall survival;Adverse event;Adverse event; | — |
Countries
China
Contacts
Public ContactYiling Li, Meng Niu
The First Affiliated Hospital of China Medical University
Outcome results
None listed