Advanced Hepatocellular Carcinoma
Conditions
Interventions
Observers:Treatment with Transarterial Chemoembolization (TACE) Combined with QL1706 (a PD-1/CTLA-4 Bispecific Antibody) and Bevacizumab
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years at the time of signing informed consent, regardless of gender; 2.Treatment-naive patients with pathologically confirmed unresectable hepatocellular carcinoma (HCC). 3.At least one measurable lesion meeting RECIST v1.1 criteria:; 4.Barcelona Clinic Liver Cancer (BCLC) stage B or C; China Liver Cancer (CNLC) stage IIb to III; 5.ECOG Performance Status score: 0-1. 6.Child-Pugh class A or B (score =3 months; 8.Hematological Parameters (no transfusion or cytokine support within 2 weeks): a) Hemoglobin (Hb) >=90 g/L b) Absolute Neutrophil Count (ANC) >=1.5×10^9/L c) Platelet Count (PLT) >=55×10^9/L Biochemical Parameters (no albumin infusion within 14 days): a) Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT)=28 g/L d) Serum Creatinine (Cr)=50 mL/min (Cockcroft-Gault formula) if Cr >1.5×ULN e) Thyroid-Stimulating Hormone (TSH)=2+, 24-hour urine protein =50%; 9.Female patients of childbearing potential: Negative serum pregnancy test within 3 days prior to initial treatment; Must be non-lactating; Must use highly effective contraception from signing informed consent until 6 months after last study drug dose. Male patients with partners of childbearing potential: Must use highly effective contraception from signing informed consent until 6 months after last study drug dose. 10.Medically suitable for transarterial chemoembolization (TACE) therapy; 11.Voluntarily participates in the study, signs informed consent, and demonstrates good compliance with follow-up requirements.
Exclusion criteria
Exclusion criteria: 1.Patients with known: Fibrolamellar hepatocellular carcinoma, Sarcomatoid hepatocellular carcinoma, OR Combined hepatocellular-cholangiocarcinoma (cHCC-CCA) with >30% cholangiocarcinoma components. 2.Patients with any active, known, or suspected autoimmune disease, including but not limited to: Myasthenia gravis, myositis, autoimmune hepatitis, interstitial pneumonia, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, or hyperthyroidism. Exceptions: Type 1 diabetes managed with stable insulin doses; Hypothyroidism requiring only hormone replacement therapy; Skin disorders without systemic treatment and no acute exacerbation within 1 year prior to screening. 3.Systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 1 month before initial treatment. Exceptions: Inhaled/topical corticosteroids; Adrenal replacement therapy =10 mg/day prednisone equivalent. 4.History of grade 4 hypersensitivity reactions to any monoclonal antibody; 5.Known central nervous system (CNS) metastases OR History of hepatic encephalopathy. 6.Hepatic tumor burden >50% of total liver volume OR Prior liver transplantation. 7.Symptomatic ascites or pleural effusion requiring drainage, OR drainage within 2 weeks before treatment. Exception: Asymptomatic minimal fluid on imaging. Uncontrolled or moderate/severe pericardial effusion. 8.Other malignancies within 5 years or concurrently active (except cured basal cell carcinoma or cervical carcinoma in situ). 9.Blood pressure =140/90 mmHg despite antihypertensive therapy; History of hypertensive crisis or encephalopathy. 10.NYHA Class =II heart failure; Unstable angina; Myocardial infarction within 1 year before treatment; Clinically significant arrhythmias requiring intervention. 11.Hereditary/acquired bleeding disorders or thrombophilia; Current anticoagulant/thrombolytic therapy. Exceptions: Prophylactic low-dose aspirin (=100 mg/day) or LMWH (=40 mg/day). 12.Clinically significant bleeding within 3 months ; Exclusion if gastroscopy shows: Severe gastric ulcer, High-risk esophageal varices, Other investigator-judged bleeding risks. 13.History of GI perforation or fistula within 6 months before initial treatment. 14.Radiologically confirmed tumor invasion of major blood vessels with investigator-assessed risk of life-threatening hemorrhage. 15.Arterial/venous thrombotic events within 6 months prior to treatment, including: Cerebrovascular accidents (TIAs, cerebral hemorrhage, infarction) Deep vein thrombosis (DVT) Pulmonary embolism (PE). 16.Subjects who have received previous surgery (except diagnostic surgery), radiotherapy, chemotherapy, macromolecular targeted therapy, or anti-tumor immunotherapy, and the time from the completion of treatment (last medication) to the first treatment is less than 4 weeks; subjects who have received small-molecule targeted drugs (including other oral targeted drugs used in clinical trials), and the time from the last medication to the first treatment is less than 5 half-lives or 4 weeks (whichever is shorter); subjects who have received previous palliative radiotherapy or local treatment, and the time from the completion of treatment to the first treatment is less than 2 weeks. 17.Prior anti-cancer therapy-related toxicities not recovered to =Grade 1 per NCI-CTCAE v5.0. Exceptions: Lymphopenia, alope
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactJiansong Ji
Lishui Central Hospital
Outcome results
None listed