hepatocellular carcinoma
Conditions
Interventions
one arm:Camrelizumab: 200mg, ivgtt, 30 min per infusion (not less than 20 min, not more than 60 min), q3w
Apatinib mesylate: 250mg, oral, qd.
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 years old =75 years old, both male and female; 2. Patients with hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or cytology; 3. After radical resection, no residual lesions were determined by TACE or other imaging examinations 4 to 8 weeks after surgery (as judged by the investigator); 4. Preoperative presence of one or more of the following factors: 1) Single tumor lesion > 5cm; 2) Multiple tumors or satellite foci with > 3 foci; 3) Invasion or absence of tumor envelope (MV-type I, ?); 4) Infiltration of large hepatic vessels or microvessels of tumor cells (MV); 5) tumor rupture; 6) Low differentiation of tumor cells; 7) AFP > 32ng/ml after operation; 8) Concurrent portal hypertension; 9) There were no residual lesions in extrahepatic metastases after conversion therapy; 5. Child-Pugh classification of liver function is grade A or B (5-7 points); 6.ECOG PS score 0-1; 7. Expected survival =12 weeks; 8. If the patient has active hepatitis B virus (HBV) infection: Hbv-deoxyribonucleic acid (DNA) must be < 2000 IU/mL (< 12,500 copy/mL if the study center only has copy/mL testing units), and anti-HBV therapy must be received for at least 14 days prior to the start of study therapy (treatment according to local standard therapy, Such as entecavir) and are willing to receive antiviral therapy throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE level 1 elevation; 9. The laboratory test value of the patient before medication shall meet the following criteria: 1) Blood routine: WBC=3.0 × 109/L; ANC=1.5 × 109/L; PLT=100 × 109/L; HGB= 9.0g /dL 2) Liver function: AST=2.5 x ULN; ALT=2.5 × ULN; TBIL=1.5 x ULN 3) Kidney function: Cr=1.5 × ULN or CrCl =50 mL/min 4) Coagulation function: INR=1.5, APTT=1.5 ×ULN; 5) Thyroid function: Thyroid stimulating hormone (TSH) is in the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled. 10. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with contraindications to immunotherapy, including but not limited to the following: patients after transplantation, patients with severe autoimmune diseases, patients with organ failure, patients with grade 4 or above adverse reactions after immunotherapy, patients with uncontrollable infectious diseases, etc.; 3. Immunosuppressive agents or systemic hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression; 4. Patients who have proven allergic to carrilizumab injections, Apatinib mesylate tablets and its excipients or to other monoclonal antibodies; 5. Patients with consciousness disorder or can not cooperate with treatment, combined with mental illness; 6. Patients who have participated in other clinical trials in the past three months; 7. Severe liver, kidney, heart, lung, brain and other major organ failure; 8. Hereditary bleeding tendency or coagulation dysfunction. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline; 9. Patients with other concomitant diseases that, in the judgment of the investigator, endanger the patient's safety or interfere with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival(DFS);overall survival(OS);safety; | — |
Countries
China
Contacts
Public ContactYansong Zheng
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed