Primary hepatocellular carcinoma
Conditions
Interventions
Test group:Radiotherapy: 3Gy x 10-15F,then Donafenib 0.1g or 0.2g qd+sintilimab 200mg d1, Q3W
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Over 18 years old; 2. Sign informed consent and be willing to participate in this study; 3. The life expectancy is more than 12 weeks; 4. It is clinically diagnosed as hepatocellular carcinoma or pathologically confirmed as hepatocellular carcinoma. The tumor stage is CNLC phase IIIa-IIIb or BCLC phase C, with portal vein tumor thrombus (programmed types are type I, II and III) 5. No previous history of targeted and immunotherapy 6. According to the evaluation standard of solid tumor curative effect (according to RECIST 1.1 standard, the long diameter of CT scanning of tumor lesions >=10mm, and the short diameter of CT scanning of lymph node lesions >=15mm), at least one imaging measurable lesion 7. ECOG score is less than or equal to 1; 8. Child Pugh score =100 g/L, neutrophil >=1.5x10^9/L and platelets >=100x10^9/L;Total bilirubin =60 ml / min, urea nitrogen <=0.2g/l; The urine test paper value of proteinuria is less than 1 +; If the test value of urine test paper is more than 1 +, the total urinary protein in 24 hours must be less than 500mg.
Exclusion criteria
Exclusion criteria: 1. Patient >=75 years old; 2. Patients with cholangiocarcinoma confirmed by pathology or patients who do not meet the above stages; 3. Previous liver transplantation; 4. Those with serious mental or nervous system diseases that affect informed consent and / or adverse reaction expression or neurocognitive function evaluation; 5. Suffering from diseases affecting the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.); 6. The patient is known or suspected to have a history of allergy to donafenib or similar drugs, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergic to the excipients of the study drugs; 7. Have serious chronic diseases of heart, kidney, liver and other important organs, such as hyperthyroidism, heart failure, etc; 8. Pregnant or lactating women, or those who are fertile and do not take adequate contraceptive measures; 9. Received any other research drugs and used targeted and immune drugs in the past 4 weeks before enrollment; 10. Have a history of immune deficiency, or suffer from other acquired and congenital immune deficiency diseases, or have a history of organ transplantation;Patients with previous history of stroke and / or myocardial infarction, active bleeding, previous massive bleeding and uncontrollable or uncontrollable hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;organ-specific response rate;Overall survival;time to progression; | — |
Countries
China
Contacts
Public ContactZeng Chuan
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed