Hepatocellular Carcinoma
Conditions
Interventions
TACE/Ablation + Sintilimab + Ipilimumab N01:TACE/Ablation combined with Sintilimab 200mg ivdrip Q3W + Ipilimumab N01 3mg/kg ivdrip Q3W
TACE/Ablation + Sintilimab + Ipilimumab N01 + Lenvatinib:TACE/Ablation combined with Sintilimab 200mg ivdrip Q3W + Ipilimumab N01 3mg/kg ivdrip Q3W + Lenvatinib 8mg P.O QD
Sintilimab + Ipilimumab N01:Sintilimab 200mg ivdrip Q3W + Ipilimumab N01 3mg/kg ivdrip Q3W
Sintilimab + Ipilimumab N01 + Lenvatinib:Sintilimab 200mg ivdrip Q3W + Ipilimumab N01 3mg/kg ivdrip Q3W + Lenvatinib 8mg P.O QD
Sponsors
The First Afliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years 2. Hepatocellular carcinoma patients with CNLC stage Ib-IIIa, excluding those with Vp3 and Vp4 portal vein invasion, who are deemed resectable by multidisciplinary team (MDT) discussion 3. No prior anti-tumor treatment received 4. At least one measurable target lesion in accordance with the RECIST v1.1 criteria 5. ECOG PS score of 0 to 1 6. Expected survival time of >=12 weeks 7. Child-Pugh Class A liver function 8. Hematological, hepatic and renal functions meeting the following criteria: (1) Hemoglobin >=90 g/L (2) Absolute neutrophil count (ANC) >=1.5×10^9/L (3) Platelet count >=75×10^9/L (4) Total bilirubin =30 g/L 9. Female patients of childbearing potential must have a negative pregnancy test 10. For patients with a history of other malignant tumors, the past tumor history and treatment history must be confirmed by MDT discussion to not interfere with the efficacy and safety assessment of this study protocol 11. Capable of understanding and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Tumor rupture and bleeding with suspected peritoneal metastasis 2. A history of other complex surgeries within 6 weeks 3. A history of previous organ transplantation 4. Currently receiving treatment in other clinical trials 5. A history of previous autoimmune diseases, inflammatory dysregulation (e.g., inflammatory bowel disease, etc.), diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome, Wegener’s syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, etc., with the following exceptions: vitiligo or alopecia areata, hypothyroidism with stable condition after drug replacement therapy, chronic skin diseases not requiring systemic treatment, celiac disease controllable by diet alone 6. A history of previous hypersensitivity to anti-PD-1 agents, anti-angiogenic agents or anti-CTLA-4 agents, or hypersensitivity to chemical molecules similar to the above drugs, or a history of severe anaphylactic reactions to other monoclonal antibodies in the past 7. Uncontrollable intermittent recurrent diseases, including but not limited to: persistent infections (including tuberculosis), medically uncontrolled hypertension (> 140/90 mmHg), interstitial lung disease, severe chronic gastrointestinal diseases complicated with diarrhea, mental disorders or social disorders that prevent compliance with clinical study requirements, presence of risk factors for high-risk adverse events, inability to sign the informed consent form 8. Patients with a history of hepatic encephalopathy, refractory ascites, or esophagogastric varices with a high bleeding risk; patients with a history of upper gastrointestinal bleeding within 1 year prior to the first dose 9. Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA > 5000 copies/mL (1000 IU/mL) or above the lower limit of detection, whichever is higher) — for subjects with hepatitis B, anti-hepatitis B virus therapy is required during the study treatment; Subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection) 10. Suffering from primary brain tumors (excluding meningiomas or other benign brain tumors), or any brain metastases, leptomeningeal carcinomatosis, epilepsy uncontrolled by conventional drugs, or a history of newly diagnosed stroke within the past year 11. Suffering from primary immunodeficiency diseases 12. A history of positive HIV test or acquired immunodeficiency syndrome (AIDS) in the past 13. Use of immunosuppressive drugs within 14 days prior to the start of study treatment. Exceptions apply for the following situations: (1) Intranasal, inhaled, topical corticosteroids or local corticosteroid injections (2) Systemic administration of corticosteroids not exceeding physiological doses (e.g., 10 mg/day prednisone or its equivalent) (3) Corticosteroid administration for the treatment of anaphylactic reactions 14. Vaccination with live-attenuated vaccines within 30 days prior to the start of study treatment. Note: Live-attenuated vaccines should also be avoided during the study treatment and within 30 days after the end of treatment 15. Receipt of systemic immunostimulant therapy within the previous 4 weeks 16. A history of previous severe systemic diseases, including: myocardial infarction or unstable angina pectoris, hypertensive crisis or hypertensive encephalopathy, congestive heart failure of NYHA Class II or higher, unstable symptomatic arrhythmias requiring medical intervention, severe vascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-Year Recurrence-Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate (MPR Rate);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactKuang Ming
The First Afliated Hospital of Sun Yat-sen University
Outcome results
None listed