liver cancer
Conditions
Interventions
Test group:Deb-tace combined with sorafenib and carrelizumab
control group:Deb-tace combined with sorafenib
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Primary liver cancer confirmed by pathology, histology or imaging; 2. Aged 18-75 years; 3. The CNLC is staged as IIb IIIa; 4. Have not received other anti-tumor treatment in the past; 5. Child pugh score = 7; 6. ECOG score 0-1; 7. No extrahepatic metastasis; 8. For patients with hepatitis B, they must meet the requirements of HBV-DNA<500 IU/mL, and must receive antiviral treatment according to the treatment guidelines; In the case of hepatitis C patients, HCV-RNA positive patients must receive antiviral treatment according to the guidelines.
Exclusion criteria
Exclusion criteria: 1. Patients not suitable for TACE treatment; 2. They have received live attenuated vaccine treatment within 4 weeks before enrollment, or they are expected to be vaccinated during the treatment of carelizumab or within 60 days after the last administration of carelizumab; 3. Patients who have received organ or allogeneic bone marrow transplantation in the past; 4. Use immunosuppressant or systemic hormone in the last month; 5. Congenital or acquired immune deficiency (such as HIV infection) 6. Have a history of gastrointestinal bleeding disease or have a clear gastrointestinal bleeding tendency in the first 6 months; 7. Complicated with other malignant tumor diseases before enrollment; 8. Within 6 months before entering the study, patients who have the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia and need clinical intervention; Hypertension with poor drug control (continuous increase of systolic blood pressure = 150mmHg or diastolic blood pressure = 100mmHg); 9. Systemic use of antibiotics = 7 days within 4 weeks before the first administration, or fever of unknown cause>38.5 ° C during screening/before the first administration (according to the judgment of the investigator, fever caused by tumor can be included in the group); 10. Patients who are not suitable for this study according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;mPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;DCR;OS; | — |
Countries
CHINA
Contacts
Public ContactMAFUQUAN
Outcome results
None listed