Tumor cardiovascular
Conditions
Interventions
Control group:Placebo injection (0.9% sodium chloride injection)
Experimental group:Tafolecimab Injection
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are admitted to this study: 1) Subjects should be fully informed and obtain written informed consent before the screening procedure; 2) 18 years old =80 years old, regardless of gender; 3) Pathological confirmation of gastrointestinal malignancy; 4) According to RECIST version 1.1, there must be at least a measurable lesion that has been shown by imaging examination; 5) The ECOG physical status of the patient was 0-1; 6) The patient has adequate organ function, defined as: a) Blood system: absolute neutrophil count (ANC) =1.0×109/L, platelets =70×109/L, hemoglobin =80 g/L; b) Heart function: left ventricular ejection fraction (LVEF) =50%; c) Liver function: total bilirubin =1.5 times the upper limit of normal (ULN) (<2.0×ULN for subjects with documented Gilbert syndrome; <3.0×ULN) for subjects with indirect bilirubin levels indicating extrahepatic elevation; Without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN; In the presence of liver metastasis, ALT and AST=5 times ULN; d) Kidney function: serum creatinine (Scr) =1.5×ULN, or creatinine clearance (Ccr) =50mL/min (according to Cockcroft and Gault formula); e) Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) or International Normalized ratio (INR) (if receiving prophylactic anticoagulant therapy) =1.5 times ULN; 7) The expected survival time is greater than 3 months.
Exclusion criteria
Exclusion criteria: Subjects who meet one of the following criteria are excluded from the study: 1) People with severe allergies to the main components and excipients of immune checkpoint inhibitors and PCSK9 inhibitors, or allergic constitution; 2) has not recovered to = grade 1 or baseline levels from the toxic effects of previous antitumor therapy (except for alopecia and = grade 2 neuropathy); 3) is currently participating in and receiving investigational therapy or has received another investigational therapy within 3 months prior to the first investigational drug use; 4) Pregnant or breastfeeding female patients; 5) Subjects for other factors deemed unsuitable by the researcher; 6) Incomplete data, failure to cooperate with treatment, failure to follow up on time, loss of follow-up or withdrawal of researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Cardiac function; | — |
Countries
China
Contacts
Public ContactBai Ming
The First Hospital of Lanzhou University
Outcome results
None listed