Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Sorafenib 400mg / bid orally, tislelizumab, 200mg / q3w intravenously
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participated in this study and agreed to sign the informed consent form, and the compliance and follow-up were good; 2. The subjects must be over 18 years old when they sign the informed consent form, regardless of gender; 3. Advanced hepatocellular carcinoma diagnosed by imaging or histological examination, not suitable for radical surgery and/or local treatment, or disease progression after surgery and/or local treatment; 4. At least one measurable lesion (according to RECIST version 1.1): measurable long diameter of the lesion >= 10 mm or lymphadenopathy short diameter >= 15 mm in spiral CT scan; 5. Have not received any systemic therapy for HCC in the past; 6. The ECOG score is 0 or 1, and the expected survival is greater than 3 months; 7. Definition of intolerance: hematological toxicity >= grade IV, or non-hematological toxicity >= grade III, or treatment center, liver and kidney damage >= grade II; 8. Liver function evaluation: Child-Pugh A (=4x10^9/L, neutrophils>=2x10^9/L, hemoglobin>=90g/dL, platelet>=80x10^9/L. (2) Liver function: bilirubin = 3 g/dL; International Normalized Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) = 60 mL/min according to the Cockcroft-Gault formula.
Exclusion criteria
Exclusion criteria: 1. Active or untreated CNS metastases (eg, brain or leptomeningeal metastases) as determined by CT or magnetic resonance (MRI) assessment during screening and prior imaging assessment. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (monthly or more frequently), allow the patient to have an indwelling catheter; 2. Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN); patients who received denosumab before enrollment must agree to discontinue denosumab treatment and switch to bisphosphonate replacement therapy after entering the study; 3. Patients with a history of liver transplantation or preparing for liver transplantation; 4. Suffering from serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable; 5. Those with a history of hepatic encephalopathy; 6. History of pulmonary tuberculosis under activity; 7. History of gastrointestinal bleeding or tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varices, locally active ulcer lesions, fecal occult blood >= (++) (gastroscopy is required when fecal occult blood is positive); esophagogastric varices with bleeding risk indicated by gastroduodenoscopy are not eligible); 8. Serious non-healing wounds, ulcers or fractures; 9. Patients with a history of malignant tumors other than liver cancer within 5 years before enrollment, however, except for malignant tumors with negligible risk of metastasis or death [eg expected 5-year overall survival > 90%] and expected to be cured with treatment such as appropriately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative surgery, and ductal carcinoma in situ of the breast treated with curative surgery; 10. Have a history of autoimmune diseases, or other diseases that require immunosuppressive therapy; 11. Patients who have received hormone therapy 4 weeks before enrollment; 12. Patients who have received antibiotic treatment 2 weeks before enrollment; 13. Patients who have received other immune checkpoint inhibitors; 14. Patients who are pregnant, breastfeeding or planning to become pregnant during the study period; 15. Patients who have received other experimental drug treatment or participated in clinical research for other therapeutic purposes within 28 days before enrollment; 16. Presence of substance abuse, or any medical, psychological or social condition that may affect research, patient compliance or even safety; 17. Variable factors affecting drug use and absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 18. Any live virus vaccine within 30 days prior to this study, except for seasonal influenza vaccine without live virus; 19. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia; current or recent (within 10 days prior to initiation of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular-weight heparin is permitted); 20. Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the start of s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Objective response rate (ORR);Disease control rate (DCR);Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Time to progress; | — |
Countries
China
Contacts
Public ContactChe Xu
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Outcome results
None listed