Hepatocellular carcinoma
Conditions
Interventions
Case series:SHR-1210 intravenous medication
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 and 70 years male or female; 2. ECOG PS 0 to 1 point. 3. The clinical diagnosis is consistent with primary hepatocellular carcinoma and the lesion meets the indications for surgical resection in the Diagnostic Guidelines for Primary Hepatocellular Carcinoma (2019) edition. (1) Intraoperative visual and postoperative imaging, pathological confirmation of complete resection without residual cancer; (2) No hepatic, portal, inferior vena cava, bile duct invasion beyond the scope of removal; (3) Negative resection margin: pathologically confirmed, AFP reduced to normal within 1 month, no lymph node invasion, no distant metastasis; 4. Patients who have not received any tumour-related targeted, immune, radiotherapy or chemotherapy before inclusion in the group; 5. Patients with at least one measurable lesion according to RECIST 1.1 criteria (CT scan long diameter >=10mm for measurable lesions or short diameter >=15mm for lymph node lesions, and the measurable lesion has not been treated locally with radiotherapy, cryotherapy, etc.); 6. Expected survival period >=3 months; 7. The main organ functions meet the following criteria; (1) Hemoglobin (HB) >=80 g/L (no transfusion within 14 days), neutrophils (ANC) >=1.5x10^9 /L, platelet count (PLT) >= 100x10^9/L; (2) Total bilirubin (TBIL) =60mL/min; (4) Activation Partial Thrombin Activation Time (APTT) and International Normalized Ratio (INR) <=1.5 ULN (screenable for use of stable doses of anticoagulation therapy such as low molecular heparin or warfarin and INR within the expected therapeutic range of anticoagulants); (5) Thyrotropin (TSH) <=ULN; if abnormal, T3 and T4 levels should be examined, and T3 and T4 levels are normal, they are eligible for selection; 8. No residual tumor lesions were confirmed on imaging and AFP negative within 1 month after surgery. 9. Females of childbearing age should agree to be required to use contraception (e.g. IUD, pill or condom) during the period of drug use and for 6 months after the end of drug use; those with a negative serum or urine pregnancy test within 7 days before entry into the study and must be non-lactating patients, and males should agree to be required to use contraception during the study and for 6 months after the end of the study period; 10. Subjects voluntarily enrolled in the study, signed an informed consent form, followed well and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. A history of past allergy to any component of carfilizumab; 3. The presence of extrahepatic metastases; 4. Patients with early-stage hepatocellular carcinoma (CNLC) stage Ia; (CNLC Ia: PS 0-2, hepatic function Child-pugh A/B, single tumor, maximum diameter grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggestive of active pulmonary inflammation, signs and symptoms of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic therapy (excluding prophylactic use of antibiotics); 9. Patients with active autoimmune diseases, a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); hypothyroidism in autoimmune diseases treated with stable doses of thyroid replacement hormones; type 1 diabetes with stable doses of insulin; but not purpura or cured childhood asthma/allergies that require no intervention as adults; 10. A history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunodeficiency diseases, or a history of organ and bone marrow transplants; 11. History of interstitial lung disease and non-infectious pneumonia; 12. Patients with active tuberculosis infection detected by medical history or CT examination, or with a history of active tuberculosis infection in the year before admission, or with a history of active tuberculosis infection in the year before but without regular treatment; 13. Known history of psychotropic substance abuse, alcoholism and drug use; 14. Those the researcher deems inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival;3-year progression-free survival;pCR %;Rate of marked pathological remission; | — |
Countries
China
Contacts
Public ContactXiao Zhiyu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed