thrombocytopenia Induced by concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer
Conditions
Interventions
Control group (Phase Two):None
Prevention Group (Phase One):hetrombopag
Non-prevention group(Phase One):none
Experimental group (Phase Two):hetrombopag
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, any gender; 2. Patients with limited-stage small cell lung cancer confirmed by pathological histology or cytology, planning to undergo concurrent chemoradiotherapy, with a chemotherapy regimen of carboplatin plus etoposide (Q21d), expected to receive >= 2 cycles of treatment; 3. Expected survival >= 12 weeks at screening; 4. Performance status: ECOG PS score 0-2; 5. Laboratory test criteria meet the following requirements: (1) Renal function: Cr = 55 ml/min; (2) Liver function: total bilirubin <= 1.5 × ULN; ALT and AST <= 3 × ULN; 6. Women of childbearing potential agree to use contraception during the study and for 6 months after completion, and are not breastfeeding; male patients agree to use contraception during the study and for 6 months after completion; 7. Have not participated in other drug or device clinical trials within 4 weeks prior to enrollment; 8. Expected to have good compliance, able to follow up on efficacy and adverse reactions according to protocol; 9. Subjects able to understand the study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Thrombocytopenia caused by non-tumor treatments within the 6 months prior to screening, including but not limited to cirrhosis with hypersplenism, infections, and bleeding; 2. Other hematologic diseases except for chemotherapy-induced thrombocytopenia (CTIT), including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndromes; 3. Patients with bone marrow infiltration or bone marrow metastasis; 4. Hemoglobin still <80 g/L after red blood cell transfusion or erythropoietin (EPO) treatment, or absolute neutrophil count still <1.0×10^9/L after granulocyte colony-stimulating factor (G-CSF) treatment; 5. Severe cardiovascular disease within the 6 months prior to screening (e.g., NYHA class III-IV heart failure), known arrhythmias that increase the risk of thromboembolism such as atrial fibrillation, or patients after coronary stent implantation, angioplasty, or coronary artery bypass graft surgery; 6. Known or expected allergy or intolerance to the active ingredient or excipients of avatrombopag ethanolamine tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose, magnesium stearate, film coating premix); 7. Lactating women; 8. Vulnerable populations, including individuals with mental illness, cognitive impairment, critically ill patients, minors, and pregnant women; 9. Participants deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade >=3 CTIT during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Incidence of chemotherapy and/or radiotherapy suspension or delay due to thrombocytopenia during the treatment period;patient reported outcome (PRO);Incidence of chemotherapy dose reduction due to thrombocytopenia during the treatment period;Proportion of patients who received at least one platelet-raising salvage therapy during the treatment period;Incidence of grade >=2 CTIT during the treatment period; | — |
Countries
China
Contacts
Public ContactYuan Shuanghu
The First Affiliated Hospital of Ustcanhui Provincial Hospital
Outcome results
None listed