Hepatocellular carcinoma
Conditions
Interventions
Trial group:QL1706 combined with lenvatinib is administered (one treatment cycle every 3 weeks), followed by as-needed TACE (total of 2–3 sessions), until disease progression, intolerance, initiation
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent form; 2. Age >=18 years, either sex; 3. Diagnosed with hepatocellular carcinoma by histopathology, cytology, or imaging (CT/MRI); 4. Patients with CNLC stage Ib/IIa/IIb/IIIa/IIIb or BCLC stage A/B/C hepatocellular carcinoma; 5. Patients with progression after local therapy or residual disease after local therapy (e.g., post-ablation). Local therapy (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation, percutaneous ethanol injection, or TACE) must be completed within 1 month prior to enrollment, and toxicity related to local therapy (except alopecia) must have recovered to =12 weeks; 11. Laboratory values within the following limits within 3 days prior to first dose: (1) Complete blood count (excluding hemoglobin; no blood transfusion, G-CSF, or pharmacological correction within 2 weeks prior to screening): 1) Absolute neutrophil count >=1.5×10^9/L; 2) Platelets >=75×10^9/L; 3) Hemoglobin >=90 g/L; (2) Biochemistry: 1) Serum albumin >=30 g/L; 2) Total bilirubin 50 mL/min; (3) International Normalized Ratio (INR) =2+, a 24-hour urine protein quantification may be performed; if 24-hour urine protein <1.0 g, the patient is eligible); 12. For patients with hepatitis B virus (HBV) infection (HBsAg positive), HBV-DNA must be tested, and antiviral therapy must be administered throughout the study. Patients with positive HCV-RNA must receive antiviral treatment according to guidelines; 13. Women of childbearing potential must have a negative pregnancy test (ß-hCG) prior to first dose. Women of childbearing potential and men having sexual relations with women of childbearing potential must agree to use contraception during treatment and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Portal vein tumor thrombosis reaching or exceeding the main portal vein, with concurrent complete occlusion of the main portal trunk or complete occlusion of both the left and right portal branches. 2. Patients who are severely allergic to iodinated contrast agents and cannot undergo TACE treatment. 3. History of hepatic encephalopathy. 4. Previous allogeneic stem cell or solid organ transplantation, or being on the waiting list for liver transplantation. 5. Active tuberculosis. 6. History of autoimmune or immunodeficiency diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. 7. Bleeding events within 6 months before the first dose due to untreated or inadequately treated esophageal and/or gastric varices. 8. Clinically significant ascites. 9. History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before the first dose. 10. Prior use of systemic immunostimulants or immune checkpoint blockade therapy. 11. Known allergy to any of the investigational drugs or excipients. 12. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the investigational drug, may interfere with the interpretation of results, or may place the patient at high risk of treatment complications; pregnancy, breastfeeding, or women of childbearing potential who refuse to use contraception. 13. Any other factors deemed by the investigator as inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Disease Control Rate;Safety endpoints (including: incidence and severity of adverse events and serious adverse events, vital signs, laboratory abnormalities, ECOG PS score, Child-Pugh score);Duration of Response; | — |
Countries
China
Contacts
Public ContactZhang Qingqiao
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed