Thrombocytopenia in patients with ovarian cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female, aged >= 18 years; 2. The patients were clinically diagnosed as ovarian cancer, fallopian tube cancer and primary peritoneal cancer; According to the standards of the International Federation of Gynecology and Obstetrics (FIGO), all patients suffered from classified high-grade serous or endometrioid ovarian cancer, primary fallopian tube cancer and primary peritoneal cancer; 3. The patient developed thrombocytopenia of grade 1 or above (platelet count<100 × 10 ^ 9/L), and plans to continue to receive Nilapalide treatment, which requires intervention on patients with thrombocytopenia; 4. The patient's physical status score of the Eastern American Oncology Collaboration Group (ECOG) was 0 or 1; 5. The patient must be able to take drugs orally and be able to complete this clinical research process; 6. Any previous toxicity and side effects of the patient have recovered to the level of CTCAE <= 1 or baseline, except for sensory neuropathy or alopecia with stable symptoms of CTCAE <= 2; 7. Written informed consent should be signed prior to any study related procedures.
Exclusion criteria
Exclusion criteria: 1. The patient was diagnosed with mucinous, clear cell subtypes of epithelial ovarian cancer, carcinosarcoma, or undifferentiated ovarian cancer; 2. Patients who are known to be allergic to the active or inactive ingredients of Nilaparil or to other drugs with a similar chemical structure to Nilaparil; 3. Patients who underwent major surgery 3 weeks before the start of the study, or who were affected by any surgical effects that had not recovered after the surgery; 4. Patients who received >20% bone marrow palliative radiotherapy 3 weeks before enrollment; 5. Patients with invasive cancers other than ovarian cancer (except treated cervical carcinoma in situ, non-melanoma, ductal carcinoma in situ) within 5 years prior to enrollment; 6. Thrombocytopenia caused by drugs other than antitumor therapy, such as antibiotics, heparin, etc.; 7. In addition to malignant tumor (solid tumor), the patient is also complicated with other hematological diseases, including immune thrombocytopenia, aplastic anemia, myelodysplastic syndrome, hematological malignancies, etc.; 8. Patients with chronic liver diseases, including chronic hepatitis B, chronic hepatitis C, alcoholic liver disease, non-alcoholic fatty liver disease, cirrhosis of various causes, liver failure, etc.; 9. The patient had severe acute infection; 10. Patients who are pregnant or nursing, or expect to plan pregnancy during the course of the study treatment; 11. Patients with other serious or uncontrollable diseases, including but not limited to: (1) Uncontrolled nausea and vomiting, inability to swallow the study medication, and any gastrointestinal disorders that may interfere with drug absorption and metabolism; (2) Human immunodeficiency virus (HIV) infection, active hepatitis (hepatitis B, hepatitis C); (3) Uncontrolled ventricular arrhythmias, myocardial infarction occurring within 3 months prior to enrollment; (4) Uncontrollable grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome, or other mental illness that may affect the patient's ability to sign informed consent; (5) Immune deficiency (other than splenectomy) or other medical conditions, as the researchers believe, may put the patient at high risk; 12. Patients with medical records have participated in any clinical study of any other investigational drug or medical device within 30 days prior to medication, except observational studies; 13. The investigator considers that there are any other factors unsuitable for inclusion or affecting participation in or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine blood test; | — |
Countries
China
Contacts
Peking Union Medical College Hospital