Hepatocellular carcinoma associated thrombocytopenia
Conditions
Interventions
Research Group:Oral medication (3mg/ day) for 7 consecutive days
Control group:Blank control
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Advanced hepatocellular carcinoma was clinically or pathologically diagnosed; ? 18-75 years old; ? History of cirrhosis; ? Initial platelet count =75×10^9/L; ? Cancer treatment-induced thrombocytopenia (CTIT) occurred after preoperative conversion therapy (targeting/immunotherapy) (< 75×10^9/L), and the preoperative level did not recover after drug withdrawal =7 days (=75×10^9/L); ?After preoperative conversion therapy, the tumor SD/PR/CR, (according to mRECIST criteria), and radical hepatectomy is planned; ? Child-pugh A, B;
Exclusion criteria
Exclusion criteria: ? Solid malignancies other than hepatocellular carcinoma ? Always present with thrombosis or current or previous conditions (e.g., cerebral infarction, myocardial infarction, angina pectoris, coronary artery carotid artery stenting and angioplasty, coronary artery bypass grafting, congestive heart failure, known to increase the risk of thromboembolic events with arrhythmias such as atrial fibrillation, pulmonary thromboembolism, deep vein thrombosis, or disseminated intravascular coagulation syndrome). ? A known history of hereditary prothrombotic syndrome (such as coagulation factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency); ? Received platelet or platelet-containing blood products within 7 days before screening; ? Used erythropoietin within 7 days before screening; ? Used rhTPO, TPO receptor agonists (such as avatrombopag, eltrombopag, hetrombopag or romiplostim) or received splenic embolization within 30 days before screening ? The investigator believes that the accompanying medical history may affect the subject's safe completion of the study; ? The investigator believes that there are any other factors that may be unsuitable for inclusion or affect study participation or completion ? HIV-infected persons; ? Known or suspected of continuous alcoholism or drug abuse; ? Breastfeeding or pregnant at the time of screening, or Female subjects who plan to become pregnant during the study; ?According to the standard, preoperative anticoagulation or antiplatelet therapy should not be suspended (continuation of low-dose aspirin is allowed) ? At screening, hemoglobin level of male patients =9.0g/dL or =18.0g/dL, female patients>15.0g/dL, and hematocrit of male patients =0.54, female patients =0.45; ? Bleeding score =2 at screening (according to the World Health Organization Bleeding Scale) ? Participation in another clinical study within 30 days before screening, use of any exploratory drugs or devices; participation in observational studies is allowed ? Known allergy to lusutrombopag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with preoperative platelet count = 75 × 10^9/L (platelet count measured one day before surgery) and platelet count increased by more than 20% compared with before treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative blood loss;Operation time;Liver function index;Drainage tube retention time;Postoperative red blood cell count and hemoglobin content of drainage fluid;Postoperative hospital stay;Thrombosis incidence;Platelet count; | — |
Countries
China
Contacts
Public ContactHong WU
West China Hospital of Sichuan University
Outcome results
None listed