CTIT
Conditions
Interventions
experimental group:Accept subcutaneous administration of romiplostim N01: 3ug/kg once a week, adjust the dosage according to the patients platelet count until the platelet count is >= 50 × 10^9/L, for
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 999 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Gastrointestinal tumor or digestive gland tumor confirmed by histology or pathology, including but not limited to: esophageal cancer (including cancer at the junction of esophagus and stomach), gastric cancer, small intestine cancer, hepatobiliary cancer (bile duct cancer, gallbladder cancer, hepatocellular carcinoma), pancreatic cancer, colorectal cancer, etc. 3. Thrombocytopenia caused by tumor treatment, and PLT count<50 × 109/L; 4. ECOG score 0-2; 5. Individuals with normal bone marrow hematopoietic function; 6. The patient has not previously received treatment with Lopside N01; 7. Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and IUD placement) throughout the study period; 8. Patients whom researchers believe can benefit; 9. Voluntarily participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from hematopoietic system diseases other than thrombocytopenia caused by tumor treatment, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, myelodysplastic syndrome, etc; 2. Screening for thrombocytopenia caused by non tumor therapy within the first 6 months, including but not limited to splenic hyperfunction, infectious bleeding, etc; 3. History of severe cardiovascular disease within 6 months prior to screening, such as congestive heart failure (NYHA heart function score III-IV), arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, coronary stent implantation, angioplasty, and coronary artery bypass surgery; 4. History of arterial or venous thrombosis within 6 months prior to screening; 5. Clinical manifestations of severe bleeding within the two weeks prior to screening, such as gastrointestinal or central nervous system bleeding; 6. Within the week prior to screening, have used other platelet stimulating drugs; 7. Received platelet transfusion within 3 days prior to enrollment; 8. Patients who are known or expected to be allergic or intolerant to rosuvastatin N01 or excipients; 9. HIV infected individuals; 10. Pregnant or lactating women; 11. Have participated in other clinical trials within 28 days prior to enrollment; 12. Researchers believe that participating in the trial poses significant risks to the health or safety of participants, or other situations that may affect the evaluation of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients whose PLT recovered to >= 50 × 10^9/L two weeks after receiving treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve platelet response within 7 days of treatment;The time required for PLT to recover to >= 50 × 10^9/L after receiving treatment;The time required for PLT to recover to >= 100× 10^9/L after receiving treatment;The lowest platelet count from the beginning of treatment to the end of treatment;Proportion of patients receiving platelet transfusion;Incidence of adverse reaction events; | — |
Countries
China
Contacts
Public ContactHe YIfu
Anhui Provincial Cancer Hospital
Outcome results
None listed