Thrombocytopenia due to concurrent/sequential chemoradiation
Conditions
Interventions
Cohort 1:Hetrombopag combined IL-11
Cohort 2:Hetrombopag
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent form; 2. Age>=18 years, male or female; 3. Histopathological or cytological examination confirmed the diagnosis of malignant tumors; 4. Patients are currently receiving concurrent/sequential chemoradiotherapy regimen need to use one or more of the following chemotherapeutic drugs: 1)antimetabolites, including gemcitabine, capecitabine or fluorouracil; 2) platinum, including carboplatin, nedaplatin, platinum, etc.; 3)anthracyclines, including adriamycin, daunorubicin, epirubicin, etc.; 4)alkylating agents, including cyclophosphamide, ifosfamide, etc.; 5. Platelets =12 weeks at screening, and can receive at least 1 cycle of current regimen treatment; 8. Subjects of childbearing age, agree to take reliable contraceptive measures throughout the study (including male or female condoms, contraceptive foam, contraceptive glue, contraceptive film, contraceptive ointment, contraceptive suppositories, Abstinence and placement of intrauterine device, etc.); except for female subjects who have undergone hysterectomy, salpingectomy, tubal ligation or more than 1 year after menopause and male subjects who have undergone vasectomy or ligation; 9. Voluntarily participate in this study, sign the informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1.Screening or baseline platelet value < 30 × 10^9/L; 2. suffering from the following other hematopoietic diseases except thrombocytopenia (CIT) caused by cancer chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma and myelodysplastic syndrome; 3. thrombocytopenia caused by causes other than CIT within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding; 4. received thrombopoietin receptor agonists (such as eltrombopag, romistim) treatment within 1 month before screening; 5. received platelet transfusion 3 times before entering the group; 6. known or expected to be allergic to or intolerant patients with high altitude park ethanolamine tablets and recombinant human interleukin-11 for injection active ingredients or excipients; 7. pregnant or lactating women; 8. investigators believe that participating in the trial has a greater risk to the health or safety of subjects, or other conditions that may affect the efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery of platelet values to>= 75 × 10^9/L;Rate of patients with platelet values returned to>=75 x 10^9/L; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients with platelet values recovered to >=100 x 10^9/L;Time to recovery of platelet values to >=100 × 10^9/L;Platelet count increased from baseline; | — |
Countries
China
Contacts
Public ContactWang Jun/Zhou Zhiguo
Fourth Hospital of Hebei Medical University
Outcome results
None listed