hepatocellular carcinoma
Conditions
Interventions
Experiment group:High-dose irradiation plus low-dose radiatlion combined with tislelizumab and lenvatinib
Sponsors
Pingxiang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Hepatocellular carcinoma confirmed by histology/cytology, or in accordance with the clinical diagnostic criteria of primary liver cancer in the 2019 edition of the Chinese Code of Diagnosis and Treatment for Primary Liver Cancer. 2. Barcelona Clinic Liver Cancer(BCLC) Stage C disease or Barcelona Clinic Liver Cancer (BCLC) Stage B disease that is not amenable to or has relapsed after locoregional therapy and is not amenable to a curative treatment approach. 3. Patients have at least one measurable lesion according to RECIST V1.1 (solid Tumor Response Evaluation Criteria); 4. Age is between 18 and 75 years old; 5.ECOG score: 0-1; 6.Liver function Child-Pugh score = 7; 7. Expected survival >3 months; 8. All premenopausal women (no amenorrhea = 12 months) had a negative serum pregnancy test; 9. For female patients who have not undergone menopause (no amenorrhea = 12 months) or have not been surgically sterilized and all male patients: consent to the use of effective contraception for themselves and their partners during treatment and within 7 months after the last dose of the study treatment. 10. Patients have adequate organ and bone marrow functions, and the laboratory test values within 7 days before enrollment meet the following requirements:1) LVEF by echocardiography = 55%; 2) Hematology: white blood cell count =3.0×10E9/L, hemoglobin =90 g/L, absolute neutrophil count =1.5×10E9/L, platelet count =75×10E9/L; 3) Liver and kidney function: total bilirubin =2×ULN, aspartate aminotransferase =5×ULN, alanine aminotransferase =2.5×ULN, alkaline phosphatase =5×ULN, serum albumin =28 g/L, serum creatinine =1.5×ULN; 4) Urine routine: urine protein < 2+; 5) Coagulation function: International standardized ratio (INR) =1.5ULN; Partial prothrombin time (APTT) =1.5×ULN; 11. Patients Understand and voluntarily sign a written informed consent that the investigator judges will comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients have a history of other malignant tumors, except cured cervical carcinoma in situ or skin basal cell carcinoma; 2. Patients have a known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation; 3. Combined with untreated central nervous system metastasis; 4. Receiving other anti-tumor therapies, including chemotherapy, immunotherapy or traditional Chinese medicine; 5. Presents with any active autoimmune disease or history of autoimmune disease; 6. Use of any clinical trial drug within 4 weeks prior to randomization; 7. Patients with a history of severe hypersensitivity to the drugs; 8. Pre-HIV, anti-HCV positive, HCV RNA>10 E3 /ml, HBV sAg positive, HBV DNA =200 IU/ml or 10E3 /ml 9. Any life-threatening bleeding event occurred within 6 months prior to enrollment; 10.Thrombotic/embolic events within 6 month; 11. Presence of serious heart disease or discomfort, including but not limited to the following: 1) History of chronic heart failure (NYHA Class II to IV) within 6 months prior to signing the informed consent, 2) severe arrhythmias requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia), 3) unstable angina pectoris, 4) clinically significant valvular heart disease, 5) transmural myocardial infarction demonstrated by the ECG. 6) Poor hypertension control (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg); 12. Active or clinically poorly controlled severe infection or severe symptoms within 14 days prior to enrollment; 13. Poor diabetes control (fasting blood glucose (FBG)>10mmol/L, or blood glucose >17mmol/L 2 hours after meals); 14. Patient had an abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 2 months prior to joining the study; 15. Known hereditary or acquired bleeding and thrombotic tendencies; 16. Inability to swallow, chronic diarrhea or intestinal obstruction, which significantly affect drug administration and absorption; 17. Patients received any vaccine treatment (including anti-infection vaccine, such as influenza vaccine, chickenpox vaccine, etc.) within 30 days prior to enrollment; 18. Any history of drug (including psychotropic) or alcohol dependence or abuse within the past two years; 19. Known to have a history of severe allergy to any monoclonal antibodies, anti-angiogenesis targeted drugs and other drug ingredients in this study; 20. Pregnant or lactating women; 21. Patients have complications that may interfere with the study plan, or other conditions that make it unfit to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Security; | — |
Countries
China
Contacts
Public ContactFan Cai
Pingxiang People's Hospital
Outcome results
None listed