Hapetocellular carcinoma
Conditions
Interventions
Case series:sintilimab in neoadjuvant therapy
Sponsors
The First Hospital Affiliated to The University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Imaging diagnosis of hepatocellular carcinoma; 2. Agree to collect tumor histological samples needed for this study and apply them to related research; 3. For untreated and resectable hepatocellular carcinoma, the diameter of the tumor must be more than 2cm; 4. Patients who agree to receive radical surgery; 5. Liver surgeons judge patients without surgical taboos; 6. At least one measurable lesion (RECIST v1.1); 7. Male or female aged 18 to 75 years old; 8. ECOG score 0; 9. The functions of important organs and bone marrow meet the following requirements: (1) Blood routine test: absolute neutrophil count ((ANC) >=1.5x10^9), platelet (PLT) (>=100x10^9), hemoglobin ((HGB)) >=9 g/dL; Liver function: serum total bilirubin (TBIL) 1.5 ULN, alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) =2.8g Unidl; Renal function: serum creatinine (Cr) =40 mL/min; 13. Sign a written informed consent form and be able to comply with the visit and related procedures stipulated in the program. The expression of PD-L1 in this text.
Exclusion criteria
Exclusion criteria: 1. Lamellar HCC, sarcomatoid HCC or HCC of mixed cholangiocarcinoma are known; 2. Have received any antineoplastic therapy in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine (except those with previous radical cure and no recurrence or metastasis >=5 years); 3. History of hepatic encephalopathy; 4. Ascites with clinical significance, that is, any ascites or any previous or current ascites that needs treatment through physical examination during the screening period; 5. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6. Allergic to any component of monoclonal antibody; 7. The subjects had any active, known or suspected autoimmune diseases; 8. Active brain metastasis or leptomeningeal metastasis; 9. Known history of positive detection of human immunodeficiency virus or known history of acquired immunodeficiency syndrome; 10. Suffering from other serious uncontrolled diseases, including, but not limited to: (1) serious infections that are active or clinically poorly controlled;-people infected with HIV (positive for HIV); (2) suffering from acute or chronic active hepatitis B (HBsAg-positive and HBV DNA > 1*103/ml) or acute or chronic active hepatitis C (HCV-positive and HCV RNA > 15IU/ml);-active tuberculosis, etc.; (3) Class III-IV congestive heart failure (New York Heart Association grade), poorly controlled and clinically. Meaningful arrhythmias; (1) uncontrolled arterial hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=100 mmHg); (2) any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc.; (3) diseases requiring anticoagulant therapy with farfarin (coumarin); (4) uncontrolled hypercalcemia (symptomatic hypercalcemia with calcium greater than 1.5 mmol/L or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or requiring continued bisphosphate therapy; (5) accompanied by other malignant tumors (except those that have been cured, such as cervical carcinoma in situ, non-melanoma skin cancer, etc.); 11. Other acute or chronic diseases, mental disorders, or laboratory test abnormalities that may result in: increasing the risk associated with research participation or drug administration, or interfering with the interpretation of the results of the study, and the patient was classified as not eligible to participate in this study according to the judgment of the researchers; Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety follow-up;survival time; | — |
Countries
China
Contacts
Public ContactLianxin Liu
The University of Science and Technology of China
Outcome results
None listed