Hepatocellular Carcinoma
Conditions
Interventions
Targeted Therapy and Immunotherapy Group:Receiving Lenvatinib Targeted Therapy and Immunotherapy
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-70 years, gender unrestricted; 2.Clinically or histopathologically diagnosed with hepatocellular carcinoma (HCC) (in accordance with the 2017 edition of the Diagnosis and Treatment Guidelines for Primary Liver Cancer); 3.HCC patients beyond the Milan criteria (single tumor diameter =1.5×10^9/L; platelet count >=50×10^9/L; hemoglobin >=9 g/dL; serum albumin >=2.8 g/dL. Thyroid-stimulating hormone (TSH) <=1×ULN (if abnormal, T3 and T4 levels should be evaluated; if T3 and T4 levels are normal, the patient can be enrolled). Bilirubin <=1.5×ULN; ALT and AST <=3×ULN. Serum creatinine <=1.5×ULN; 8.ECOG performance status score of 0-2; 9.Understand and sign the informed consent form, and must be willing and able to comply with the study schedule, including visits, treatment plans, laboratory tests, and other study requirements.
Exclusion criteria
Exclusion criteria: 1.Presence of major vascular tumor thrombus (main portal vein/hepatic vein/inferior vena cava tumor thrombus); regional lymph node metastasis or extrahepatic metastasis; 2.Allergy to the components of the related therapeutic drugs; 3.History or current diagnosis of other malignant tumors; 4.Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to treatment, even if treated, should be excluded. Patients with a history of active tuberculosis infection more than 1 year ago should also be excluded unless they can provide evidence of having received standard anti-tuberculosis treatment; 5.Active, known, or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy, etc.). Patients with hypothyroidism requiring only hormone replacement therapy or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) may be included; 6.History of interstitial lung disease or (non-infectious) pneumonia requiring oral or intravenous steroid treatment; 7.Requirement for long-term systemic corticosteroid therapy (equivalent to >10 mg prednisone/day) or any other form of immunosuppressive treatment. Patients using inhaled or topical corticosteroids may be included; 8.Myocardial ischemia or myocardial infarction of grade II or higher, or hypertension that cannot be controlled to normal range with medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 9.Abnormal coagulation function (PT >18 s, APTT >43 s, TT >21 s, Fbg <2 g/L), history of gastrointestinal bleeding within the past 6 months, obvious bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; 10.Pregnant or breastfeeding women; 11.Participation in clinical trials of other investigational drugs within the past 4 weeks; 12.Active infections requiring systemic treatment; 13.Human immunodeficiency virus (HIV) positive; 14.Other factors that, in the investigator’s judgment, may affect the safety or compliance of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sum of the rates of complete response (CR, meaning the tumor has completely disappeared) and partial response (PR, meaning the tumor has shrunk by 30% or more); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression(TTP);Overall Survival (OS);Progression-free Survival (PFS);Incidence of adverse reactions;Disease-free Survival (DFS); | — |
Countries
China
Contacts
Public ContactShuhong Yi
The Third Affiliated Hospital Sun Yat-sen University
Outcome results
None listed