Hepatocellular Carcinoma
Conditions
Interventions
Ttudy group:cTACE+camrelizumab+apatinib+PVE
Control group:cTACE+atezolizumab+bevacizumab
Sponsors
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female aged >=18 years; 2. Hepatocellular carcinoma that meets the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2021 Edition)"; 3. No extrahepatic metastases and portal vein tumor thrombus (Barcelona stage b), unresectable as assessed by the surgeon, but there is a potential opportunity for surgery after the tumor shrinks significantly; 4. No previous treatment; 5. At least 1 measurable lesion meeting RECIST v1.1 or mRECIST criteria; 6. Liver function is Child-Pugh Class A; 7. ECOG PS 0~1 before entering the group; 8. Sufficient organ and bone marrow function: WBC>= 2.5*10^9/L, N%>= 1.5*10^9/L; PLT >= 50*10^9/L; Hbg >= 90 g/ L; ALB>= 28 g/L; TBIL= 3 months; 10. Women of childbearing age who have not undergone surgical sterilization should take effective contraceptive measures from the time of enrollment to 3 months after the end of the trial; women of childbearing age who have undergone surgical sterilization have negative serum and urine HCG results within 72 hours before enrollment; female Must be non-nursing; males with partners of childbearing age must use effective contraception from enrollment to the last dose of camrelizumab; 11. Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, patients with vitiligo. For patients with a history of asthma, patients with complete remission of asthma in childhood and no intervention in adulthood can be included in the trial, but patients with asthma requiring pharmacological intervention with bronchodilators are not included); 2. The patient is using immunosuppressive or systemic hormone therapy (dose > 10 mg/day prednisone or other therapeutic hormones) to suppress immune function and continue to use it within 2 weeks before enrollment; 3. CNS metastases or hepatic encephalopathy; 4. Severe allergic reactions to other monoclonal antibodies; 5. Have a history of organ transplantation; 6. For patients with ascites with clinical symptoms, puncture and drainage should be performed within 3 months, excluding patients with a small number of ascites but no clinical symptoms; 7. Suffering from hypertension and poorly controlled antihypertensive drugs (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg after treatment); heart disease with clinical symptoms or no treatment/intervention, such as NYHA grade 2 or above Heart failure, unstable angina pectoris, history of myocardial infarction within 1 year, clinically apparent supraventricular or ventricular arrhythmia requiring treatment/intervention, QTc > 450 ms (male)/QTc > 470 ms (female); 8. Abnormal coagulation function (INR>1.5 or APTT>1.5*ULN), bleeding tendency or receiving thrombolytic or anticoagulation therapy, low-dose aspirin, low-molecular-weight heparin can be used for prophylaxis; known hereditary or acquired bleeding and thrombophilia (eg, hemophilia, coagulation disorders, thrombocytopenia, etc.); 9. Clear clinical bleeding symptoms or high bleeding tendency within 3 months before enrollment, such as whooping cough/hemoptysis 2.5ml or more, gastrointestinal bleeding, esophagogastric varices with bleeding risk, hemorrhagic gastric ulcer or vasculitis, etc. . If fecal occult blood is positive at baseline and needs to be re-examined, and if it is still positive after re-examination, gastroscopy is required. If the esophagus and gastric fundus varices were severe in gastroscopy, the trial could not be included; 10. History of arterial/venous thrombosis within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc.; 11. Patients with congenital or acquired immunodeficiency (such as HIV-infected patients); 12. HBV DNA> 2000IU/ml or 10^4 copies/ml, HCV RNA>10^3 copies/ml, HBsAg+, anti-HCV antibody positive patients; 13. Other malignant tumors within 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 14. The patient has received other anti-PD-1 antibody therapy or other anti-PD-1/PD-L1 immunotherapy in the past, or received apatinib therapy in the past; 15. Live vaccines can be administered within 4 weeks before enrollment or during the trial; 16. The researcher believes that the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successfully Conversion Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Future liver remnant;Duration of Response;Disease Control Rate;Progression-free survival;Time-To-Progression;Overall survival;Adverse Event; | — |
Countries
China
Contacts
Public ContactSheng Yan
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed