hepatocellular carcinoma
Conditions
Interventions
Experimental group:Donafenib plus Sintilimab in combination with transarterial chemoembolisation
Sponsors
Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patient voluntarily joins the study and signs an informed consent; 2.Aged 18 to 75 years, both men and women; 3.Clinical or pathologically confirmed BCLC B(4 = 1.5 x 10^9 / L; Platelets >= 50 x 10^9 / L; Hemoglobin >= 80 g / L; serum albumin >= 28 g / L; Thyroid stimulating hormone (TSH) <= 1 x ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled); bilirubin <= 1.5 x ULN (within 7 days prior to the first dose); ALT <= 3 x ULN and AST <= 3 x ULN (within 7 days prior to the first dose); AKP <= 2.5 x ULN; serum creatinine <= 1.5 x ULN; 11.For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Sintilimab injection.
Exclusion criteria
Exclusion criteria: 1. The maximum liver tumor diameter >= 10 cm, tumor numbers > 10; 2. Receive local treatment for HCC((e.g.,TACE, TAE, HAIC or radiotherapy); If the treatment of ablation and/or resection > 4 weeks is permitted; 3. The patient has any active auto-immune disease or a history of auto-radioimmune disease; Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy; 4. The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment; 5. 6. Known or suspected allergy to the investigational agents or any agent given in association with this trial; 7. Known central nervous system tumors including metastatic brain disease; 8. History of organ allograft; 9. Ascites with clinical symptoms; 10. The intrahepatic neoplasms showed diffuse changes; 11. Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure >= 140mmHg or diastolic blood pressure >=90 mmHg); 12. Suffering heart diseases with clinical symptoms or those not well controlled, such as: (1) Heart failure in NYHA class 2 or higher; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Tc > 450ms (male); QTc > 470ms (female). 13. Abnormal coagulation (INR>2.0, PT extension time >4s), bleeding tendency or being treated with thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin and low-molecular-weight heparin; 14. Evidence of bleeding diathesis; Patients with clinically significant gastrointestinal bleeding within 3 months prior to study entry. 15. Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 16. Known history of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulopathy, thrombocytopenia, etc.); 17. Had intestinal obstruction and/or had clinical signs or symptoms of GI obstruction within 6 months prior to the start of study treatment, including incomplete obstruction related to pre-existing conditions or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 18.Urine routine indicates that urine protein >= ++ and 24-hour urine protein amount > 1.0g was confirmed; 19. The patient has active infection, unexplained fever (>=38.5 degree C) within 3 days before administration, or baseline white blood cell count > 15 x 10^9/L; 20. Patients with congenital or acquired immunodeficiency (such as HIV-infected patients); 21. HBV-DNA > 2000 IU/ml (or 10^4 copies/ml); or HCV-RNA > 10^3 copies/ml; or HBsAg+ and anti-HCV antibody positive patients; 22. The patient has had other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 23. Palliative radiotherapy for non-target lesions to control symptoms is permitted and must be completed at least 2 weeks prior to the start of the study treatment. The adverse events caused by radiotherapy have not recovered to <= CTCAE 1; 24. Patients have previously received other anti-PD-1 anti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response ;Disease control rate ;Progression free survival rate at 12 months;Overall survival rate at 12 months;The median progression free survival time ;The median overall survival time; | — |
Countries
China
Contacts
Public ContactChen Jinzhang
Nanfang Hospital, Southern Medical University
Outcome results
None listed