hepatocellular carcinoma
Conditions
Interventions
Experimental group:Levatinib, folfox4-haic combined with tislelizumab
Sponsors
The Second Affiliated Hospital of PLA Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 75 years; 2. Patients with hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition), or who are diagnosed by histopathology or cytology; 3. Have not received any systematic treatment for HCC in the past; 4. Patients with BCLC stage B and C liver cancer, or stage A that patients cannot be resected due to insufficient residual liver volume (normal liver: residual liver volume (RLV) / standard liver volume (SLV), SRLVR < 30%; sclerotic liver: SRLVR < 40%); Liver cancer recur within 1 year after resection or ablation and multiple lesions are found in the liver; 5. According to the evaluation criteria of solid tumor efficacy (mRECIST), at least one imaging measurable lesion must be confirmed in the liver; 6. ECOG PS score 0-1; 7. Liver function status Child-Pugh Class A, and B (7); 8. Normal blood pressure or controlled by drugs (<= 150/90mmHg); 9. Adequate organ function before study enrollment; 10. No pregnancy or pregnancy plan; 11. Signed informed consent(IC) obtained before any study specific procedure. Patients must be able to understand and willing to sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known sarcomatoid HCC, Combined hepatocellular-cholangiocarcinoma and fibrolamellar carcinoma of liver; 2. Combined with other malignant tumors under treatment; 3. Patients who are ready for or have previously received organ (except corneal transplantation) or bone marrow transplantation; 4. Known history of gastrointestinal bleeding or clear tendency of gastrointestinal bleeding within 6 months before signing the informed consent. Such as: positive erythema sign of esophageal and gastric varices, active ulcer focus and positive occult blood of continuous stool; 5. Known allergy to any monoclonal antibody; 6. Known history of mental illness or psychotropic substance abuse; 7. Active autoimmune disease or history of autoimmune disease and possible recurrence; 8. Known history of human immunodeficiency virus (HIV) infection; 9. Active infection; 10. Pregnancy or breast feeding; Patients with fertility are unwilling or unable to take effective contraceptive measures; 11. Clinical symptoms or diseases of the heart that are not well controlled; 12. Subjects with previous and current history of pulmonary fibrosis, pneumoconiosis, interstitial pneumonia within 2 months before the first use of tislelizumab, or evidence of active pneumonia or severe impairment of pulmonary function on chest CT during the screening period may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; Active tuberculosis; Radiation field radiation pneumonia is allowed; 13. Patients with acute or chronic active hepatitis B or hepatitis C infection, HBV DNA >= 200000 IU /mL or 106 copies/mL when treated with tislelizumab; HCV RNA >= 103 copies/mL; 14. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency or undergoing thrombolytic therapy; 15. Being treated with systemic glucocorticoids (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: it is allowed to use glucocorticoids in physiological doses (<= 10 mg/day prednisone or equivalent); 16. Live vaccine was administered within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines with intranasal drugs are not allowed. 17. In order to relieve pain symptoms or avoid life-threatening conditions in a short time, radiotherapy for intracranial metastasis and bone metastasis is allowed; 18. According to the researchers, the subject with conditions that may terminate of the study, such as other serious diseases or serious laboratory abnormalities, or conditions that will affect the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Conversion resection rate;Progression free survival;Overall survival;Duration of Response; | — |
Countries
China
Contacts
Public ContactDu Xilin
The Second Affiliated Hospital of PLA Air Force Military Medical University
Outcome results
None listed