Hepatocellular carcinoma
Conditions
Interventions
Test group:Q3W, QL1706 at a dose of 5mg/kg is administered on the first day of each cycle. The dosing time window can be ±3 days. However, within 72 hours before each administration, except for imagin
Sponsors
Taixing People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for this trial, the subjects must meet all of the following inclusion criteria: 1. Voluntary participation in this study and signing the informed consent form; 2. Age >= 18 years, regardless of gender; 3. Advanced liver cancer confirmed by histopathology, cytology or imaging; 4. Liver cancer that has failed or is intolerant to previous systemic treatment; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6. ECOG PS score: 0 - 1; 7. Child-Pugh liver function classification: A/B (= 12 weeks; 9. Laboratory test values within 3 days before the first dose meet the following requirements: (1) Blood routine test: (Except for hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], and no drug correction within 2 weeks before screening): - Absolute neutrophil count >= 1.5×10^9/L; - Platelet count >= 75×10^9/L; - Hemoglobin >= 90 g/L; (2) Biochemical tests: - Serum albumin >= 30 g/L; - Serum total bilirubin 50 mL/min (3) International normalized ratio (INR) = 2+, 24-hour urine protein quantification can be performed, and subjects with 24-hour urine protein quantification < 1.0g can be enrolled); 10. For subjects with hepatitis B virus (HBV) infection: at least one week of anti-HBV treatment before enrollment and willingness to receive antiviral treatment throughout the study period; subjects with positive hepatitis C virus (HCV) RNA must receive antiviral treatment according to treatment guidelines and liver function elevation within CTCAE grade 1; 11. Women of childbearing age must have a negative pregnancy test (ßHCG) before the first dose. Women of childbearing age and men (having sexual relations with women of childbearing age) must agree to use contraception during the treatment period and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will not be included in the study: 1. Presence of unresolved toxicities (excluding alopecia, non-clinically significant and asymptomatic laboratory abnormalities) from previous anti-tumor treatment at a grade higher than 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) before the first dose of study treatment; 2. History of hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis of Child-Pugh B grade or worse; 3. Receipt of local liver treatment (transcatheter arterial chemoembolization [TACE], transcatheter arterial embolization [TAE], hepatic artery infusion [HAI], radiotherapy, radioembolization, or ablation) within 4 weeks before the first dose; 4. History of other active malignancies within 5 years or concurrently with HCC, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, cervical intraepithelial neoplasia, and breast intraepithelial neoplasia; 5. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment; 6. Active tuberculosis; 7. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis; 8. Severe infection within 4 weeks before the first dose, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia; 9. Oral or intravenous antibiotic treatment within 2 weeks before the first dose; 10. Bleeding events due to untreated or incompletely treated esophageal and/or gastric varices within 3 months before the first dose; 11. Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 3 months before the first dose; 12. Uncontrolled arterial hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) based on the average of >= 2 blood pressure readings, allowing for the use of antihypertensive therapy to achieve these parameters; history of hypertensive crisis or hypertensive encephalopathy; 13. Severe cardiovascular disease (such as New York Heart Association class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months before the first dose; 14. History of intra-abdominal inflammation within 1 month before the first dose, including but not limited to peptic ulcer, diverticulitis, or colitis; 15. History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 1 month before the first dose; 16. Severe, non-healing or open wounds, active ulcers, or untreated fractures; 17. Core needle biopsy or other minor surgery within 3 days before the first dose, excluding placement of vascular access devices; 18. Major surgery within 4 weeks before the first dose or expected to require major surgery during the study period; 19. Systemic immunosuppressive drug treatment (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall suivival;Disease control rate;During of response; | — |
Countries
China
Contacts
Public ContactLiang Gu
Taixing People's Hospital
Outcome results
None listed