Hepatocellular carcinoma
Conditions
Interventions
Experimental group:6 months treatment of PD-1 monoclonal antibody combined with lenvatinib
Control group:3 months treatment of PD-1 monoclonal antibody combined with lenvatinib
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients between the ages of 18 and 75; 2. Child-pugh liver function grading (see attachment): Grade A; 3. ECOG score (see attachment) : 0-1; 4. Hepatocellular carcinoma was diagnosed according to primary Liver Cancer Diagnosis and Treatment Guidelines (2022) Edition; IIb and IIIA; 5. After R0 resection after transformation therapy with TACE and/or sintinimab and/or lenvatinib, postoperative histopathological examination indicated that the tumor had achieved pCR or MPR; 6. One month after surgery, imaging confirmed no residual tumor lesions, negative for alpha-fetoprotein (AFP) and abnormal prothrombin (PIVKA-II); 7. Blood routine examination: absolute neutrophil count >= 1.5 x 10^9/L, Hb >= 8.5g/L, PLT >= 75 x 10^9/L; 8. No history of serious arrhythmia or heart failure; No history of severe ventilation dysfunction or serious lung infection; No acute or chronic renal failure, creatinine clearance rate & GT; 40 mL/min. 9. Women of childbearing age should agree to use contraception during and for six months after the use of the drug; A negative serum or urine pregnancy test in the seven days before study enrollment must be a non-lactating patient, and men should agree to use contraception during the study period and for six months after the study period.
Exclusion criteria
Exclusion criteria: 1. Extrahepatic metastasis or invasion of nearby organs; 2. Use other anti-tumor treatments before surgery, such as HAIC, FOLFOX systemic chemotherapy, and Huaier granule drug treatment; 3. History of allergy to lenvatinib, PD-1 antibody, and its components; 4. Patients with any active autoimmune diseases or autoimmune diseases with expected recurrence (e.g., interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); hypothyroidism treated with stable doses of thyroid replacement hormones; type 1 diabetes with stable doses of insulin; but not purpura or cured childhood asthma/allergies that require no intervention as adults; 5. A history of immunodeficiency the patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes; 6. Known hereditary or acquired bleeding (such as coagulation disorders) or thrombophilia, such as in patients with hemophilia; current or recent (within 10 days prior to initiation of study treatment) full-dose oral or Injection of anticoagulant drugs or thrombolytic drugs (prophylactic use of low-dose aspirin, low molecular weight heparin is allowed); 7. Severe infection (CTC AE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging examinations suggest the presence of active pulmonary inflammation, symptoms and signs of infection or need for oral or intravenous antibiotic treatment within 2 weeks before the first use of study drug (excluding prophylactic use of antibiotics); 8. Proteinuria patients with >= 1+ urine tests will receive a 24-hour urine protein test, and patients with 24-hour urine protein >= 1 g; 9. A history of other malignant tumors within the last five years or at the same time, except for cured basal cell carcinoma of the skin and cervical cancer in situ and papillary thyroid cancer; 10. Patients complicated with mental illness; history of psychotropic substance abuse, alcoholism, and drug use; 11. Pregnant or breastfeeding women; 12. According to the investigator's judgment, patients with obvious surgical contraindications such as renal and heart and lung dysfunction, and patients with other reasons considered by the investigator should not participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Recurrence rate; | — |
Countries
China
Contacts
Public ContactYan Maolin
Fujian Provincial Hospital
Outcome results
None listed