Hepatocellular carcinoma
Conditions
Interventions
Treatment group:QL1706
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Patients with HCC who have not received any prior treatment (who meet the AASLD 2018 diagnostic guidelines for liver cancer resection and are confirmed by postoperative pathology); 3. Positive for microvascular invasion (MVI); 4. Stage A of the Barcelona Clinic Liver Cancer (BCLC) staging system; 5. The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score is 0; 6. Child-Pugh Class A; 7. Life expectancy >= 3 months; 8. Blood, liver and kidney functions meet the following criteria: a) Neutrophil count >= 1.5 × 10?/L; b) Platelet count >= 75 × 10?/L; c) Hemoglobin concentration >= 90 g/L; d) Serum albumin concentration >= 30 g/L; e) Bilirubin <= 50 µmol/L; f) AST and ALT < 5×ULN, ALP < 4×ULN; g) INR <= 2.3; h) Creatinine < 1.5×ULN; 9. Women of childbearing potential must agree to use contraceptive measures (such as intrauterine devices, contraceptive pills, or condoms) during the study period and for 6 months after the end of the study; they must have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients. Male patients must agree to use contraceptive measures during the study period and for 6 months after the end of the study; 10. The patient voluntarily participates in this study, signs the informed consent form, and demonstrates good compliance.
Exclusion criteria
Exclusion criteria: 1. Previously treated with QL1706; 2. Preoperative imaging examination shows diffuse infiltrative lesions in the liver, or tumor invasion of large blood vessels or primary bile ducts; 3. Failure to achieve R0 resection as evaluated by postoperative pathology; 4. Contrast-enhanced CT/MR or digital subtraction angiography (DSA) performed 4–6 weeks postoperatively reveals tumor recurrence; 5. Have been diagnosed with immunodeficiency or are receiving long-term systemic steroid therapy; received such therapy (at a dose exceeding 10 mg/day prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study treatment; 6. Having an active autoimmune disease that required systemic therapy (i.e., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is permitted; 7. Have a history of (non-infectious) pneumonia requiring steroid therapy or currently suffer from pneumonia; 8. Having an active infection requiring systemic treatment; 9. Individuals infected with HIV/syphilis; 10. Having a known medical history of active tuberculosis (Mycobacterium tuberculosis); 11. Patients allergic to intravenous contrast agents; 12. Pregnant or lactating women or subjects planning to use contraception within two years; 13. Concurrent occurrence of other malignant tumors within 5 years prior to enrollment; 14. Patients who have received allogeneic organ transplants; 15. Persons with severe functional impairment of organs such as the heart and kidneys; 16. Suffering from a mental illness that may affect the informed consent process; 17. The patient has participated in other drug clinical trials within 12 months prior to enrollment; 18. Evidence of any past or present condition, treatment, or abnormal laboratory test result that may confound trial outcomes or interfere with the subject's participation in the entire trial, or where the investigator deems participation in the study not to be in the subject's best interest; 19. Severe hypersensitivity (>= Grade 3) to QL1706.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival (RFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Adverse Event Record; | — |
Countries
China
Contacts
Public ContactShen Jie
Nanjing Drum Tower Hospital
Outcome results
None listed