Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Transarterial Chemoembolization
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients volunteered to join this study and signed informed consent; 2. Age >= 18 years old, both men and women; 3. Primary hepatocellular carcinoma diagnosed by pathology/clinic, or recurrence after radical resection of primary hepatocellular carcinoma; According to China liver cancer stage II-III (CNLC stage) or Barcelona clinical liver cancer stage (BCLC stage), it is classified as stage B/C, and it is not suitable for surgery and/or local treatment; 4. According to the clinical data and laboratory data in the screening period, the Child Pugh of liver function status is grade A; 5. Imaging progress after only receiving TKI combined with IO or bevacizumab combined with IO; 6. At least one measurable lesion (according to requirements of RECIST 1.1 and mRECIST v1.1); 7. ECOG score: 0 - 1; 8. The main organ functions are basically normal and meet the requirements of the scheme; The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during screening): (1) Absolute neutrophil count >= 1.5 x 10^9/L; (2) Platelets >= 80 x 10^9/L; Hemoglobin >= 9 g/dl; Serum albumin >= 3 g/dl; (3) Thyroid stimulating hormone (TSH) = 60 mL/min (using standard Cockcroft-Gault formula); The results of urine routine showed that urine protein was less than 2+; For patients whose routine urine test shows that urine protein is >= 2+ at baseline, 24-hour urine collection should be carried out and the 24-hour urine protein quantity should be < 1 g; 9. Women of childbearing age must confirm their non-pregnancy status before entering the group, and all participants (male or female) should take adequate contraceptive measures during the whole treatment period and within 4 weeks after the treatment.
Exclusion criteria
Exclusion criteria: 1. Known hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibreboard cell carcinoma; Having other active malignant tumors except HCC within 5 years or at the same time; 2. Patients who are ready to undergo or have previously received organ or allogeneic bone marrow transplantation; 3. Moderate and severe ascites with clinical symptoms requires therapeutic puncture and drainage; 4. Have a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within 6 months before the start of the study; 5. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study treatment; 6. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency; 7. Aspirin ( > 325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol are currently being used or recently used (within 10 days before the start of the study treatment); 8. Thrombosis or embolism occurred within 6 months before the start of study treatment; 9. There are clinical symptoms or diseases of the heart that are not well controlled; 10. Suffering from hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); Hypertensive crisis or hypertensive encephalopathy has occurred in the past; 11. Major vascular diseases occurred within 6 months before the start of study and treatment; 12. Severe, unhealed or split wounds and active ulcers or untreated fractures; 13. Received major surgical treatment (except diagnosis) within 4 weeks before the start of the study treatment or expected major surgical treatment during the study period; 14. Can't swallow pills, malabsorption syndrome or any condition that affects gastrointestinal absorption; 15. Have suffered from intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting the study and treatment; 16. There is evidence that there is pneumoperitoneum that cannot be explained by puncture or recent surgical operation; 17. Past or present central nervous system metastasis; 18. Those with a history of hepatic encephalopathy; 19. Past and present history of pulmonary fibrosis, organized pneumonia (for example, bronchiolitis obliterans), interstitial pneumonia, pneumoconiosis, drug-related pneumonia and idiopathic pneumonia; 20. Have any active autoimmune disease or have a history of autoimmune disease and expect recurrence; 21. Severe infection, acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA > 2000 IU/ml or 10^4 copies/ml within 4 weeks before the start of study and treatment; Hepatitis C virus (HCV) RNA > 10^3 copies/ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were both positive. 22 patients with congenital or acquired immune dysfunction (such as HIV infection); 23. Previous treatment with Regofibril; 24. Any contraindications of TACE therapy, repafenib, PD-1 immunosuppressant or idarubicin; 25. Received live attenuated vaccine treatment within 28 days before starting the study treatment, or expected to need to be vaccinated during the treatment of Pd-1 immunosuppressant or within 60 days after the last administration of pd-1 immunosuppressant; 26. Have received other experimental drugs within 28 days before starting the study treatment; 27. Female subjects who are pregnant,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease control rate;Adverse Event; | — |
Countries
China
Contacts
Public ContactXuehao Wang
Jiangsu Provincial People's Hospital
Outcome results
None listed