Hepatocellular carcinoma
Conditions
Interventions
experimental group:Modified DEB-TACE+Lenvatinib+Camrelizumab
Sponsors
Linyi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign an informed consent form. 2. Age = 18 years old, both male and female. 3. Subjects diagnosed with HCC through histopathology/cytology or clinically diagnosed with HCC according to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition)". 4. Subjects confirmed by histopathology must be able to provide fresh or archived tumor tissues (Formaldehyde#Forms fixed, paraffin embedded [FFPE] tissue blocks or at least 3 unstained FFPE slides) and their pathological reports; If the subject is able to provide less than 3 unstained slides or the tumor tissue is not available (for example, due to previous diagnostic tests being exhausted), after discussing each case with the medical supervisor, admission may be allowed based on the specific situation. 5. CNLC staging: Stage IB-IIIB (BCLC staging B or C), with a tumor diameter greater than 7cm. 6. Child Pugh liver function rating within 7 days before enrollment: A or B (= 7 points). 7. ECOG PS score within 7 days before enrollment: 0-1 points. 8. I have not received systematic anti-tumor treatment for hepatocellular carcinoma in the past. 9. Evaluated by researchers as suitable for TACE treatment. 10. Subjects who have previously undergone radical surgery or ablation are allowed to undergo a preventive TACE after surgery. 11. Expected survival time = 12 weeks. 12. The main organ functions meet the following requirements (within 7 days before enrollment): (1) Routine blood examination: (excluding hemoglobin, no blood transfusion, no use of granulocyte Colony-stimulating factor [G-CSF], no use of drugs for correction within 14 days before screening): Absolute neutrophil count = 1.5 × 10 ^ 9/L; Platelets = 50 × 10 ^ 9/L; Hemoglobin = 90g/L. (Leukocyte and thrombocytopenia caused by hypersplenism can be included after partial embolization of the splenic artery or medication correction) (2) Blood biochemical examination (no albumin transfusion within 14 days before screening): Serum albumin = 28g/L; Total serum bilirubin = 1.5 × ULN; ALT and AST = 3 × ULN; Blood creatinine = 1.5 × ULN or Cr clearance rate>50ml/min (Cockcroft Fault formula is as follows): Male: Cr clearance rate=(140 age) × Weight)/(72 × Blood Cr) Female: Cr clearance rate=(140 age) × Weight)/(72 × Blood Cr) × zero point eight five Body weight unit: kg; Blood Cr unit: mg/ml; (3) International standardized ratio (INR) = 2.3 or Prothrombin time (PT) exceeds the range of normal control = 6 seconds; (4) Urinary protein<2+(If urinary protein = 2+, 24-hour urine protein quantification is required, and 24-hour urine protein quantification<1.0g can be included in the group). 13. If you have hepatitis B virus (HBV) infection, the HBV DNA must be<2000IU/mL (if the research center has only copy/mL detection unit, it must be<10000copy/mL), and you are willing to receive antiviral treatment throughout the study period (treatment according to the diagnostic and treatment guidelines, such as Entecavir) and regular monitoring; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to diagnostic and treatment guidelines, and their liver function must be within CTCAE1 level elevation. 14. Subjects with esophageal and gastric varices need to be evaluated or treated before enrollment. 15. Women with Fertility: must agree to contraception from signing the informed consent form to 6 months after the last TACE treatment or 90 days after
Exclusion criteria
Exclusion criteria: 1. Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma of liver and fibrolamellar cell carcinoma; Within 5 years or simultaneously suffering from other active malignant tumors other than hepatocellular carcinoma. Cured local tumors, such as skin Basal-cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate Carcinoma in situ, cervical Carcinoma in situ, breast Carcinoma in situ, can be included in the group. 2. Vp4 portal vein invasion (Vp classification by the Japanese Society for Liver Cancer Research). 3. There is uncontrollable extrahepatic metastasis, such as lung and brain metastasis (EHS). 4. Intrahepatic lesions account for = 70% of the liver volume. 5. At present, it is suitable for patients undergoing radical Sex therapy such as surgical resection, ablation or transplantation. 6. Previously received local treatment, including therapeutic TACE, transarterial embolization (TAE), hepatic artery infusion chemotherapy (HAIC), and transarterial radiation embolization (TARE). a) Note: Subjects who have previously received radical local treatment (such as ethanol injection (PEI) or radiation therapy) are allowed to be included in the group, but lesions treated locally cannot be used as target lesions. 7. Subjects who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation. 8. People with interstitial pneumonia or Interstitial lung disease at present, or with a history of interstitial pneumonia or Interstitial lung disease requiring hormone treatment in the past, or other Pulmonary fibrosis, organic pneumonia (such as Bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia Subjects with idiopathic pneumonia or evidence of active pneumonia on screening chest computed tomography (CT) images or severely impaired lung function are allowed to have radiation pneumonia in the radiation field; Active tuberculosis. 9. At present, there is active autoimmune disease or a history of autoimmune disease and it may recur (including but not limited to: Autoimmune hepatitis, interstitial pneumonia, Uveitis, enteritis, hypophysitis, Vasculitis, nephritis, hyperthyroidism, hypothyroidism [only subjects that can be controlled through hormone replacement therapy can be included]); Subjects with skin diseases that do not need systematic treatment, such as Vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects requiring medical intervention with Bronchiectasis cannot be included. 10. Suffering from hypertension and unable to achieve good control through antihypertensive medication treatment (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg) (based on the average of BP readings obtained from = 2 measurements), the above parameters are allowed to be achieved through the use of antihypertensive therapy; Previously experienced hypertension crisis or hypertensive encephalopathy. 11. Moderate or severe ascites with clinical symptoms require therapeutic puncture, drainage, or a Child Pugh score>2 (excluding those with only a small amount of ascites displayed on imaging but without clinical symptoms); Uncontrolled or moderate or more Pleural effusion and pericardial effusion. 12. There are clinical cardiac symptoms or diseases that are not well controlled, such as:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival,OS;progression-free survival,PFS; | — |
Countries
China
Contacts
Public ContactYu Guangji
Linyi Cancer Hospital
Outcome results
None listed