Thrombocytopenia caused by immunotherapy combined with chemotherapy for lung cancer (CTIT)
Conditions
Interventions
Experimental group:Ropromostim 2.0 mcg/kg subcutaneously once weekly
Sponsors
Tianjin Cancer Hospital Airport Hospita
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be eligible for inclusion in this study: 1. Age >=18 years at the time of signing the informed consent 2. Histopathological or cytological examination, confirmed lung cancer, anti-tumor regimen is immunotherapy combined with chemotherapy, and the cycle is 21-28 days 3. Patients with high risk of CTIT clinically judged: patients with platelet count less than 50*10^9/L in the past 3 months; or patients who meet the criteria for prophylactic therapy in the Chinese Expert Consensus on the Management of Thrombocytopenia Induced by Chemotherapy for Oncology (2018 Edition). Criteria for prophylactic therapy include: (1) Patients with a platelet nadir of =50*10^9/L and =2 Previous or ongoing radiotherapy, especially for long, flat bones (e.g., pelvis, sternum, etc.) 4. Platelet count >=75*10^9/L and =9.0 g/dL and absolute neutrophil >=1.5*10^9/L during screening 5. Intermediate-high risk patients with a cardiac toxicity risk score (CRS) of >=3 and an ECOG score of 0 or 1 during screening 6. Current anti-tumor therapy falls within the scope of neoadjuvant, adjuvant, relapsed metastatic/advanced first- and second-line therapy, with an expected minimum of 2 cycles of the current regimen and a survival of >=6 months. Regimens can be 14-day, 21-day, or 28-day cycles, combined with targeted immunotherapy, etc 7. Patient provides signed informed consent
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be enrolled in this study: 1. Patients with severe cerebrovascular diseases (including but not limited to stroke, cerebrovascular accidents, etc.) or severe heart disease (such as valvular heart disease, arrhythmia, myocardial infarction, congenital heart disease, cardiomyopathy, heart failure, etc.) within 3 months 2. Thrombocytopenia caused by prior non-tumor chemotherapy drugs within 6 months, including but not limited to primary immune thrombocytopenia, EDTA-dependent pseudothrombocytopenia, hypersplenism, etc 3. Patients with aplastic anemia, myeloproliferative disorders, multiple myeloma, myelodysplastic syndrome and other hematodysplasia related diseases 4. Patients with any arterial and venous thrombotic events within the past 6 months 5. Patients who have used platelet-increasing drugs (TPO or interleukin 11) or transfused platelets within the past 1 week 6. Abnormal liver function: Patients without liver metastases: ALT/AST>3ULN (upper limit of normal) and TBIL>=3ULN Patients with liver metastasis: ALT/AST>=5ULN, TBIL>=5ULN 7. Abnormal renal function: Scr>=1.5ULN or eGFR<=60ml/min 8. Patients with uncontrolled severe infection 9. Pregnant women or those who plan to give birth during the study and breastfeeding patients 10. Any condition that, in the opinion of the investigator, is not suitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with platelet count>75 * 10 ^ 9/L after 2 cycles of anti-tumor treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients receiving salvage therapy to increase platelet count;Incidence of dose adjustment, delay, discontinuation of antitumor therapy due to thrombocytopenia;Lowest and highest values of platelet count, proportion of platelet count remaining normal during cycle of antineoplastic therapy;Bleeding score;Security; | — |
Countries
China
Contacts
Public ContactLiu Xianming
Tianjin Cancer Hospital Airport Hospita
Outcome results
None listed