hepatocellular carcinoma
Conditions
Interventions
Experimental group:TACE+Camrelizumab
Sponsors
The First Affiliated Hospital of Zhejing University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, male or female; 2. Unresectable primary liver cancer diagnosed by clinical and imaging, histological or cytological; 3. According to the "Specifications for the diagnosis and treatment of primary liver cancer (2017 edition)", the clinical stage of liver cancer in China is stage IIa, IIb or IIIa; 4. According to the mRECIST criteria, subjects must have at least one measurable target lesion that is examined by CT or MRI; 5. The US Eastern Oncology Cooperative Group (ECOG) has a behavioral status score of 0 or 1; 6. Child Pugh A/B (= 9.0g/dl, neutrophils >= 1500/mm3, PLT >= 50 x 10^9/L, serum ALB >= 28g/L, TBIL<2 mg/dL, ALT, AST< 5 times the upper limit of the normal value, the normal upper limit of BuN, Cr < 1.5 times, INR < 2.3 or PT extension < 6s; 10. Women or men of childbearing age need to be contraceptive according to the program requirements within 120 days after signing the informed consent to the last dose; 11. Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. Have active malignant tumors other than liver cancer within 5 years or at the same time. Localized tumors that have been cured, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ can be included; 2. Diffuse liver cancer or tumor size >= 50% of liver parenchyma; 3. Extrahepatic metastasis; 4. Moderate and severe ascites with clinical symptoms which need therapeutic puncture and drainage; or uncontrolled or moderate or above pleural effusion, pericardial effusion; 5. Insufficient blood supply to liver tumor lesions (insufficient blood supply means that the tumor lesion failed to show mild enhancement of the arterial phase by CT scan or MRI, and the portal vein and venous phase were reduced, showing a relatively low density); 6. Contraindications for TACE treatment according to the Specifications for the diagnosis and treatment of primary liver cancer (2017 edition); 7. No other anti-tumor treatment, including surgery, local treatment and systemic treatment, within 4 weeks before enrollment; 8. Have received an organ or allogeneic bone marrow transplant; 9. There is a history of active autoimmune disease or autoimmune disease and may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, thyroid function) Hyperthyroidism, decreased thyroid function [subjects that can be controlled only by hormone replacement therapy]; subjects with skin diseases that do not require systemic therapy such as vitiligo, psoriasis, alopecia, controlled I undergoing insulin therapy Type 2 diabetes or complete remission in childhood asthma can be included without any intervention in adults; asthma patients who require bronchodilators for medical intervention cannot be included; 10. Subjects requiring systemic treatment with corticosteroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the study drug; 11. Previous and current subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severe impaired lung function, and other subjects that may interfere with the detection and management of suspected drug-related lung toxicity; 12. Active tuberculosis; 13. Active clinically severe infection (> Grade 2 NCI-CTCAE version 5.0), except for HBV and HCV infection; 14. Clinical symptoms or diseases that are not well controlled, such as: (1) According to the New York Heart Association (NYHA) criteria for grade II or higher cardiac dysfunction or echocardiography: LVEF (left ventricular ejection fraction) 450ms (male) ); QTc > 470ms (female) (QTc interval is calculated by Fridericia formula; if QTc is abnormal, it can be detected three times in two consecutive intervals, taking the average value); 15. Uncontrolled high blood pressure; 16. Any contraindications or severe allergic reactions to the administration of camrelizumab or doxorubicin/pirarubicin; 17. In the past 6 months, there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;DMFS;DCR;DOR;safety; | — |
Countries
China
Contacts
Public ContactLi Jing
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed