Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab Injection (QL1706) in combination with bevacizumab
Sponsors
Xuzhou Medical University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. Age 18-100 years old, male or female; 3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging; 4. CNLC PHASE I-II; 5. After surgical resection or local ablation, the intraoperative pathology shows that there is no residual resection margin, or R0 is confirmed by imaging within 4~8 weeks after surgery; 6. Have at least one high-risk recurrence factor: (Definition of high-risk recurrence factors: Definition of high-risk recurrence factors: after radical surgery: presence of a single tumor >5 cm in diameter; Number of tumors>=3; concomitant vascular invasion (microvascular invasion or Vp1-2); Tumor grade III-IV; Post-ablation: 1. Single tumor >2cm but =12 months; 10. The laboratory test values within 3 days before the first dose meet the following requirements: (1) Routine blood test: (except for hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], no correction with medication within 2 weeks prior to screening): Absolute neutrophil count >=1.5×10^9/L; Platelets >=75×10^9/L; Hemoglobin >=90 g/L; (2) Biochemical examination: serum albumin >=30g/L; Serum total bilirubin 50 mL/min (3) International normalized ratio (INR) =2, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification =2000 IU/mL, at least 1 week of antiviral therapy (only nucleosides such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenol tablets are allowed) prior to the first dose, and the viral copy number decreased by more than 10-fold (1 lg) compared to before the first dose. For patients with HBV infection, antiviral therapy is required throughout the study. Hepatitis C virus (HCV)-RNA positive subjects must be on antiviral therapy as per treatment guidelines; 12. Women of childbearing potential must have a negative pregnancy test (ßHCG) before starting the first dose. Women of childbearing potential and men (sexually active with women of childbearing potential) must agree to contraception during treatment and within 6 months of the last dose.
Exclusion criteria
Exclusion criteria: 1) It is known that there are fibrotic plate HCC, sarcomatoid HCC or mixed-type cholangiocarcinoma and HCC; 2) There is evidence of residual, recurrent or metastatic disease; 3) History of hepatic encephalopathy; 4) Previous receipt of allogeneic stem cell or solid organ transplantation, or on the waiting list for liver transplantation; 5) Any treatment before HCC resection or ablation, including systemic treatment (including experimental drugs) and local treatment, such as TACE; and subjects who received more than one cycle of adjuvant TACE treatment after surgical resection; 6) Within 5 years before the first medication, there is a history of malignant tumors other than HCC, with negligible risk of metastasis or death (such as 5-year OS rate > 90%), such as fully treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 7) Co-infection with HBV and HCV, co-infection with HBV and delta hepatitis virus infection; 8) History of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or chest CT scan at screening shows evidence of active pneumonia; 9) Active tuberculosis; 10) History of autoimmune diseases or immunodeficiency diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome or multiple sclerosis; 11) Severe infection within 4 weeks before the first medication, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; 12) Received oral or intravenous antibiotic treatment within 2 weeks before the first medication; 13) Use of non-steroidal anti-inflammatory drugs (NSAIDs) for daily treatment of chronic diseases; 14) Have bleeding predisposition or significant evidence of coagulation dysfunction (without anticoagulant treatment); 15) Currently or recently using aspirin or full-dose oral or intravenous anticoagulants; 16) Hemorrhage events due to untreated or incompletely treated esophageal and/or gastric varices within 6 months before the first medication; 17) Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the first medication; 18) Inadequate control of arterial hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure >= 90 mmHg) (based on the average value of >= 2 measurements of BP readings), allowing the above parameters to be achieved through the use of antihypertensive treatment; previous occurrence of hypertensive crisis or hypertensive encephalopathy; 19) Significant uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL, or corrected serum calcium > ULN) within 6 months before the first medication; 20) Within 3 months of having severe cardiovascular diseases (such as NYHA class II or above heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmias or unstable angina pectoris; 21) Clinically significant ascites; 22) Within 6 months before the first medication, having a history of intra-abdominal inflammation, including but not limited to peptic ulcer, diverticulitis or colitis; 23) Within 6 months before the first medica
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-Free Survival at 6 months, RFS6;Relapse-Free Survival, RFS;Time To Relapse, TTR; | — |
Countries
China
Contacts
Public ContactBin Zhang
The Department of Hepatobiliary Surgery of Xuzhou Medical University Affiliated Hospital
Outcome results
None listed