Hepatocellular Carcinoma
Conditions
Interventions
Case series:camrelizumab
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Primary hepatocellular carcinoma confirmed by puncture pathology or Clinical diagnosis confirmed by combined detection of CT / MRI and tumor biomarker (AFP); 3. According to RECIST 1.1, at least one measurable lesion(>=1cm),all lesions can be completely ablated or mostly ablated (more than 80% of the total lesion area); 4. No indication for surgical resection, or patient refused surgery; 5. Child-Pugh A or B; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Expected survival period >=12 weeks; 8. Major organ function has to meet the following certeria: 1) For results of blood routine test HB>=90g/L; ANC>=1.5x10^9/L; PLT>=100x10^9/L; 2) For results of blood biochemical test ALB>=30g/L; ALT and AST=50%; 10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. The lesion is located in the hilum or the ablation area cannot reach more than 80%; 2. Hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibroblastic cell carcinoma; 3. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); 4. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 5. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA >=1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study; 6. 6 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female> 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism); 7. Severe infections within 4 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or >38.5? during screening visits or on the first scheduled day of dosing; 8. Patients with other malignancies within 5 years (except cured skin basal cell carcinoma and cervical carcinoma in situ); 9. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10. Less than 4 weeks from the last clinical trial; 11. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 12. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-To-Progression, TTP;Durarion of response, DOR;Progression free survival, PFS;Overall survival, OS;safty; | — |
Countries
China
Contacts
Public ContactLi Na
The First Hospital of Hebei Medical University
Outcome results
None listed