HCC
Conditions
Interventions
experimental group:Lenvimab + Iparomlimab and Tuvonralimab + TACE
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study by signing an informed consent form; 2. age >= 18 years old, male or female; 3. patients with surgically unresectable hepatocellular carcinoma confirmed by pathological histology and cytology; 4. potentially resectable CNLC stage Ib - IIIa hepatocellular carcinoma; 5. Patients judged by the treating physician to be suitable for hepatic artery chemoembolisation (TACE) combined with systemic drug therapy; 6. Child-pugh score: Grade A to B (=3 months; 10. Patient programme staging for combined portal vein cancer embolism: type I/II//III; 11. Not having received systemic therapy; 12. Females of childbearing potential: must agree to abstain (avoid heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the time of signing the Informed Consent Form until after the last dose of study drug. Must have a negative serum HCG test within 7 days prior to starting study treatment; and must not be breastfeeding. A female patient is considered to be of childbearing potential if she is menstruating, has not yet reached postmenopausal status (>=12 consecutive months without menstruation and no reason other than menopause has been identified), and has not undergone surgical intervention for sterilisation (e.g., hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy). 13. For male patients whose partner is a woman of childbearing potential, they must agree to abstain from sex or use a reliable, effective method of contraception for at least 120 days from the time of signing the informed consent form until the last dose of study drug. Male subjects must also agree not to donate sperm during the same time period. Male subjects whose partners are pregnant are required to use condoms and no other method of contraception. 14. Normal function of major organs, i.e. meeting the following criteria: (1) blood routine: absolute neutrophil count (ANC) >= 1.5×10^9L; platelet count (PLT) >= 75×10^9/L; haemoglobin (HGB) >=(2) Liver function: serum total bilirubin (total bilirubin, TBIL) =28 g/L; alanine aminotransferase (ALT) and aspartate transferase (AST) = 50 mL/min (Cockcroft-Gault formula); (4) coagulation: international normalised ratio (INR) <= 2, activated partial thromboplastin time (APTT) <= 1.5 times ULN. 15. Patients with active hepatitis B virus (HBV) infection must have received at least 14 days of anti-HBV therapy (based on local standard of care, e.g., entecavir) prior to the start of study treatment and be willing to receive antiviral therapy for the full duration of the study period; patients who are HCV ribonucleic acid (RNA)-positive must have received antiviral therapy in accordance with the standard of care guidelines for the local area and have a liver function of CTCAE 1. Liver function is within CTCAE grade 1 elevation; 16. Patients who, in the opinion of the investigator, could benefit.
Exclusion criteria
Exclusion criteria: 1. Known hepatobiliary ductal cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma of the liver and fibroplatysmal cell carcinoma; active malignant tumours other than hepatocellular carcinoma within 5 years or concurrently. Cured limited tumours, such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. can be enrolled; 2. There are contraindications to TACE or immunotherapy or targeted therapy, such as severe cirrhosis, moderate amount or more of ascites, liver function Child-Pugh grade C, which cannot be improved by liver protection therapy; 3. Previously received systemic therapy; 4. Portal vein cancer thrombosis typing of Cheng's type IV; 5. systemic infections or other serious infections requiring intravenous administration of antibiotics for >7 days of treatment within 2 weeks prior to the first dose, or unexplained fever >38.5 degrees during the screening period, prior to enrolment (with the exception of fever due to oncological causes in the subject, as judged by the investigator); 6. diagnosis of immunodeficiency or treatment with systemic steroids or any other form of immunosuppressive therapy or immunomodulators within 7 days prior to the first dose of study drug. 7. have symptomatic central nervous system metastases (CNS) metastases; 8. have an active or potentially relapsing autoimmune disease; 9. have hypertension that is not well controlled (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) by antihypertensive medication (based on the average of BP readings obtained from >= 2 measurements), allowing the achievement of the above parameters through the use of antihypertensive therapy; previous hypertensive crisis or hypertensive encephalopathy; 10. evidence of bleeding tendencies or severe coagulation disorders; 11. previous and/or current interstitial lung disease, pneumoconiosis, radiation pneumonitis that is assessed by the investigator to be clinically significant, as well as severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity; 12. HIV-positive patients; known active tuberculosis within 1 year prior to the first dose of study treatment; known active syphilis infection; 13. major surgical procedures or active ulcers or incompletely healed wounds (excluding central venous cannulation, tumour tissue biopsy or nasogastric tube insertion) within 1 month of first dose of study drug 14. have received a live vaccine within 4 weeks prior to the first dose of study drug 15. those who have participated in other clinical studies and used other drugs for clinical trials within 4 weeks prior to the first administration of the drug; 16. pregnant or lactating women; 17. patients with known prior hypersensitivity to large protein preparations. Contraindications and allergies to any component of the trial drug; 18. patients who, in the investigator's judgement, may increase the risks associated with the study, may interfere with the interpretation of the study results, etc., which the investigator considers unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;MPR;PFS;ORR;DCR;DFS;R0 resection rate;OS;AE; | — |
Countries
China
Contacts
Public ContactBeicheng Sun
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed