Hepatocellular carcinoma
Conditions
Interventions
Treatment group:sintilimab combined with sorafenib
Sponsors
The first hospital affliated to the USTC
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as HCC by imaging; 2. Patients who agree to collect tumor histology samples needed for the study and apply them to relevant studies; 3. The patients whose diameter is more than 2cm without any treatment and who can be resected surgically; 4. Patients who agree to receive radical surgery; 5. The liver surgeon judges the patients without contraindications; 6. Patients with at least one measurable lesion (RECIST v1.1); 7. Male or female = 18 years old and = 75 years old; 8. ECoG score 0; 9. The functions of important organs and bone marrow meet the following requirements: Blood routine test: neutrophil absolute count (ANC) = 1.5 × 109 / L, platelet (PLT) = 100 × 109 / L, hemoglobin (Hgb) = 9g / dl; Liver function: TBIL = 1.5 times of upper limit of normal (ULN), ALT and / or AST = 2.5 times of ULN, ALB = 2.8 g / dl; Renal function: serum creatinine (CR) < 1.5 × ULN, or creatinine clearance = 40 ml / min; 10. Patients who are willing to sign the written informed consent and are able to follow the visit and related procedures specified in the program.
Exclusion criteria
Exclusion criteria: 1. Patients with known fibrolamellar HCC, sarcomatoid HCC, or HCC with mixed cholangiocarcinoma. 2. Patients who have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine treatment (except for the treatment of malignant tumors with a history of radical cure and no recurrence and metastasis time = 5 years); 3. Patients with history of hepatic encephalopathy; 4. Ascites with clinical significance, i.e. patients who find any ascites or any ascites that needs treatment before or at present through physical examination during the screening period; 5. Patients who have had known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6. Patients who are allergic to any component of monoclonal antibody; 7. Patients with any active, known or suspected autoimmune diseases; 8. Patients with active brain metastasis or pial metastasis; 9. Patients with known history of HIV positive test or acquired immunodeficiency syndrome; 10. Suffer from other uncontrolled serious diseases, including but not limited to: serious infection in active period or poor clinical control; HIV infected person (HIV antibody positive); acute or chronic active hepatitis B (HBsAg positive and HBV DNA > 1 * 103 / ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA > 15iu / ml); active tuberculosis, etc; Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically proven. Significant arrhythmia; uncontrolled arterial hypertension (systolic blood pressure = 160mmhg or diastolic blood pressure = 100mmhg); any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, etc., occurred within 6 months before the selection for treatment; diseases requiring anticoagulant treatment with fawarin (coumarin); Uncontrolled hypercalcemia (more than 1.5 mmol / L calcium ion or more than 12 mg / dl calcium or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate treatment, accompanied by other malignant tumors (except those that have been cured, such as cervical carcinoma in situ, non melanoma skin cancer, etc.); 11. Patients with other acute or chronic diseases, mental illness or abnormal laboratory test values that may cause the following results: increase the risk related to study participation or study drug administration, or interfere with the interpretation of study results, and the patients are listed as unqualified for the study according to the judgment of researchers; 12. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphocyte subsets analysis;Single cell sequencing; | — |
Countries
China
Contacts
Public ContactLianxin Liu
Anhui Provincial Hospital
Outcome results
None listed