hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent; 2. Aged >= 18 years; 3. Pathologically diagnosed advanced hepatocellular carcinoma, who have not received any treatment, or have failed previous first-line treatment, including failure of sorafenib or lenvatinib treatment or hepatic arterial infusion chemotherapy, failure of TACE treatment (disease progression or intolerable toxicity), failure of immunotherapy; 4. Child-Pugh score = 12 weeks; 9. The function of vital organs meets the following requirements (the use of any blood components, cell growth factors and other drugs for corrective treatment is not allowed within 14 days before the first dose): (1) Absolute neutrophil count >=1.5x10^9/L; platelets >=80x10^9/L; hemoglobin >=90 g/L; serum albumin >=28 g/L; (2) Thyroid-stimulating hormone (TSH) <= 1xULN (if abnormal, the levels of FT3 and FT4 should be investigated at the same time, if the levels of FT3 and FT4 are normal, they can be included in the group); (3) Bilirubin<=1.5xULN (within 7 days before the first administration); ALT and AST<=3xULN (within 7 days before the first administration); AKP<=2.5xULN; serum creatinine<=1.5xULN; 10. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; Non-surgical sterilized female patients of childbearing age must have a negative serum or urine HCG test within 72 hours before study enrollment; and must be non-lactating; For male patients whose partners are women of childbearing potential, effective contraception should be used during the trial and for 3 months after the last dose of camrelizumab.
Exclusion criteria
Exclusion criteria: 1. Combined with severe heart, brain, lung, kidney and other important organ dysfunction, combined with severe infection or other serious concomitant diseases (>2 grade CTCAE Version 5.0 adverse events), those who cannot tolerate treatment; 2. Those with a history of other malignant tumors; 3. Those with a history of related drug allergies; 4. Those with a history of organ transplantation; 5. Patients with HIV infection; 6. There are drug addicts or drug abusers; 7. Those who have experienced gastrointestinal bleeding or cardiovascular and cerebrovascular events within the past 30 days of treatment; 8. Combined with mentally ill persons who are unable to give informed consent or affect the treatment; 9. Other factors that may affect patient enrollment and evaluation results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Countries
China
Contacts
Shaanxi Provincial Cancer Hospital