Status:
UNKNOWN
An Exploratory Study of Herombopag for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in NSCLC
Lead Sponsor:
Henan Cancer Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer
Detailed Description
To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small ...
Eligibility Criteria
Inclusion
- The patients signed the informed consent and voluntarily joined the study;
- Age 18-75 years old, male or female;
- Patients with stage IIIb-IV non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( ICIs) treatment;
- The investigator determined that the patient could receive hetrombopag administration;
- Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L;
- The values of laboratory tests performed for screening shall meet the following criteria:
- 1\) Blood routine examination: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×109/L; c) Platelet count (PLT) ≥ 80×109/L; 2) Biochemical tests: a) AST and ALT ≤ 3 times ULN (if there is tumor liver metastasis, ≤ 5 times ULN); b) TBiL ≤ 2 times ULN; c) Cr ≤ 2 times ULN, or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula); 7. Life expectancy at screening ≥12 weeks; 8. ECOG: 0-1; 9. The main organ functions are normal, and there are no serious complications;
Exclusion
- pregnant or breastfeeding women;
- Inability to understand the research nature of the research or to obtain informed consent;
- The investigator judges other circumstances that are not suitable for inclusion in the study;
- Thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
- Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction;
- Those with a history of blood disease or tumor bone marrow infiltration;
- Those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past;
- Arterial or venous thrombotic events within the past 6 months;
- There are currently uncontrollable infections.
Key Trial Info
Start Date :
February 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05252091
Start Date
February 20 2022
End Date
September 20 2022
Last Update
February 23 2022
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