Hepatocellular carcinoma
Conditions
Interventions
Experimental group:HAIC via hepatic arterial box combined with sindillizumab was administered
Sponsors
the Affiliated Drum Tower Hospital, Medical School of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Over the age of 18, gender is not limited; 2) Histopathological examination confirmed primary hepatocellular carcinoma; 3)Child-Pugh score =7 points; 4) Stage IB /IIIA of CNLC2019, after complete resection of tumors including cancer thrombectomy, no anti-tumor therapy was performed before radical resection of liver cancer, and no other systemic therapy was received after surgery; 5) High risk of recurrence includes any of the following: tumor > 5cm, > 3 Tumor, mVI or G3/4 pathology, preoperative AFP=400ng/ml; Cancer thrombus visible to the naked eye; History of tumor rupture; 6) Complete resection (margin negative R0) must be confirmed in the patient's pathology report; 7) Imaging examination before enrollment confirmed disease-free status for at least 4 weeks after surgery; 8)ECOG physical condition score 0-1; 9) Expected survival time > 6 months 10) Within 14 days prior to enrollment, laboratory test values must meet the following criteria (no blood transfusion, no use of hematopoietic stimulating factors and human blood albumin within 14 days prior to screening) : a. neutrophils =2.5×109/L; b. Platelet =75×109/L; c. Hemoglobin =90g/L; d. Serum bilirubin =2 times the upper limit of normal (2×ULN); e. ALT=5×ULN; f. Serum albumin =32g/L; g. Subjects who did not receive anticoagulation therapy: INR or aPTT=1.5×ULN. Participants receiving prophylactic anticoagulant therapy with an INR of 1.5×ULN and APTT within the normal range within 14 days prior to study treatment initiation were accepted for enrollment; h. Serum creatinine =1.5×ULN and creatinine clearance =50 mL/min. Creatinine clearance was estimated by Cockcroft-Gault formula. I.bhv-dna =2000cps/ml; j. If HBsAg (+) and/or HBcAb (+), antiviral therapy is required based on HBV DNA or HCV RNA test results; 11) Female subjects of reproductive age must have a negative serum pregnancy test within 14 days before the start of study treatment and be willing to use a reliable method of contraception during the trial and 60 days after the last dose of the trial drug. Male subjects whose partner is a woman of reproductive age should agree to use a reliable method of contraception during the trial and for 120 days after the last dose of the trial drug; 12) I have fully understood this study and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Known fibrolamellar carcinoma, cholangiocarcinoma and mixed hepatocarcinoma; 2) Had active malignant tumors other than liver cancer within 5 years prior to enrollment or at the same time. Cured localized tumors, including skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ; 3) There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion 4) Main portal vein cancer thrombus (Vp4), or primary branch or above of inferior vena cava and hepatic vein, or primary branch or above of bile duct, except for complete removal or excision of cancer thrombus. 5) Previously received systemic anticancer treatment for liver cancer (mainly including systemic chemotherapy, molecular targeted therapy and CTLA-4, PD-1/PD-L1 monoclonal immunotherapy) and previously received local treatment for liver cancer, Include subjects such as TACE, TAE (transcatheter arterial embolization), TARE (transcatheter arterial radiotherapy embolization) or local ablative therapy, radiotherapy, etc.; 6) Major cardiovascular and cerebrovascular disease (such as New York Heart Society Class II or worse heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or angina pectoris within 3 months before the start of study treatment; Or heart color ultrasound examination LVEF (left ventricular ejection fraction) 10mg prednisone/day) or any other form of immunosuppressive therapy is required. Participants using inhaled or topical corticosteroids may be enrolled; 11) The subject is known to have a prior allergy to macromolecular protein preparations, or any ICIs component; 12) Active infections that require systemic treatment; 13) Grade III and above myelosuppression (white blood cells less than 1.9×109/L, hemoglobin less than 79g/L, platelets less than 49×109/L); 14) Severe hepatic and renal insufficiency, serum albumin lower than 28g/L, or serum bilirubin greater than 50µmol/L, or serum alanine transferase more than 1 times of normal; 15) Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 16) Have received or will receive live vaccine within 30 days prior to enrollment; 17) Have a history of psychotropic substance abuse, alcohol abuse or drug use; 18) Other factors, as determined by the investigator, that may affect subjects' safety or compliance with the test. Such as a history of drug abuse, alcohol abuse, or drug use, such as a seriou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free Survival Rate in 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Response;Overall Survival;Recurrence-free Survival Rate in 1 years; | — |
Countries
China
Contacts
Public ContactYajuan Cao
the Affiliated Drum Tower Hospital, Medical School of Nanjing University
Outcome results
None listed