Initially unresectable hepatocellular carcinoma (HCC) patients?
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab Injection/Bevacizumab/HAIC (FOLFOX regimen)?
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.?; 2.Age >= 18 years, regardless of gender?; 3.Histologically/cytologically confirmed HCC, or meeting the clinical diagnostic criteria of the Chinese Guidelines for Primary Liver Cancer (2024 Edition), without evidence of extrahepatic metastasis?; 4.Criteria for potentially resectable HCC:?? a. ??Unsuitable for upfront surgical resection?? as assessed by the multidisciplinary team (MDT) of the research center; b. ??At least one untreated measurable lesion?? per RECIST v1.1 criteria (Note: Subjects who received prior local therapy for non-target lesions are eligible. Local treatment must be completed >= 4 weeks before baseline scans.); c. ??Tumor diameter >= 5 cm and = 3 months?; 10.Major organ functions must meet the following criteria within 7 days prior to treatment:?? ??Hemoglobin (Hb) >= 90 g/L?? ??White blood cells (WBC) >= 3.5×10^9/L?? ??Absolute neutrophil count (ANC) >= 1.5×10^9/L?? ??Platelets (PLT) >= 75×10^9/L?? ??AST and ALT = 40 mL/min; urine protein = 2+, a 24-hour urine collection must show 24-hour urine protein <1 g.?? ??Normal coagulation function, defined as International Normalized Ratio (INR) <= 1.5 and activated partial thromboplastin time (APTT) <= 1.5×ULN.?? ??Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may still be enrolled if total T3 (or free T3, FT3) and free T4 (FT4) are within normal limits.?; 11.Male subjects and female subjects of childbearing potential must use adequate contraception from the time of signing the informed consent form until 6 months after the last study treatment. Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first treatment.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Histologically/cytologically confirmed components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma?; 3.Patients with other primary malignancies within 5 years (except for adequately treated and stable conditions such as basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix)?; 4.History or current presence of central nervous system (CNS) metastases or leptomeningeal metastases?; 5.Patients with bleeding tendency, high bleeding risk, or coagulation dysfunction, including but not limited to:?? History of thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening; Hemoptysis (>= 2.5 mL per episode) within 3 months prior to screening; Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents; Investigator-assessed high risk of major gastrointestinal bleeding or other clinically significant bleeding; 6.Presence of unhealed fractures, wound dehiscence requiring intervention, or wound healing complications, as well as tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months prior to screening; 7.Major surgery (defined as grade III or higher according to surgical classification, excluding central venous catheter placement or tumor biopsy) within 4 weeks prior to the first dose, or significant trauma with incomplete recovery. 8.Major cardiovascular diseases (e.g., New York Heart Association [NYHA] Class II or higher heart disease, myocardial infarction, or cerebrovascular events within 3 months prior to study treatment initiation), unstable arrhythmias, or unstable angina; 9.Presence of active autoimmune diseases or a history of autoimmune diseases, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, hypophysitis, vasculitis, systemic lupus erythematosus, etc. Note:Exceptions include asymptomatic conditions or those requiring only stable doses of hormone replacement therapy (e.g., hypothyroidism due to autoimmune thyroiditis) or stable insulin replacement therapy for type 1 diabetes; 10.Diagnosis of immunodeficiency or anticipated requirement for systemic immunosuppressive therapy during the study treatment period, or prior use of systemic corticosteroids/immunosuppressants before the first treatment.?? Note:Exclusions apply to: Local corticosteroids (e.g., nasal sprays, inhalers) or non-systemic routes; Physiological systemic corticosteroid doses (<= 10 mg/day prednisone or equivalent); Temporary corticosteroid use for COPD-related dyspnea or allergy prophylaxis; 11.History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scans; 12.Severe infections occurring within 4 weeks prior to the initiation of study treatment, including but not limited to those requiring hospitalization (e.g., sepsis or severe pneumonia); or active infections treated with systemic anti-infective therapy within 2 weeks before the first dose (excluding antiviral therapy for hepatitis B or hepatitis C); 13.Presence of the following symptoms or diseases prior to initial treatment that remain poorly controlled despite optimal therapy:?? ??Uncontrolled hyperglycemia?? (defined as fasting blood gl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30 Questionnaire;adverse events;R0 resection rate?PCR?MPR?ORR?DCR?DoR?PFS?RFS?TTP;OS; | — |
Countries
China
Contacts
Public ContactHuikai Li
Tianjin Cancer Hospital Airport Hospital; Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed