OncoMatch/Clinical Trials/NCT06467786
Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer
Is NCT06467786 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Irinotecan hydrochloride liposome for small cell lung cancer.
Treatment: Irinotecan hydrochloride liposome — This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IV
Metastatic disease required
extensive stage small cell lung cancer diagnosed by pathology or histology; According to RECIST 1.1 standard, patients have at least one measurable target lesion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — first-line
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L, platelet count ≥ 90 x 10^9/L, hemoglobin ≥ 90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 14 days prior to laboratory examination)
Kidney function
serum creatinine ≤ 1.5x ULN
Liver function
AST and ALT ≤ 2.5x ULN (≤ 5x ULN for patients with liver invasion); Total bilirubin ≤ 1.5x ULN (≤ 3x ULN for patients with liver invasion)
Cardiac function
No long QTc syndrome or QTc interval >480 ms; no complete left bundle branch block, II or III degree atrioventricular block; no severe and uncontrolled arrhythmias; NYHA class < III; LVEF ≥ 50%; no history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, no clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on ECG within 6 months prior to recruitment
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 90 x 10^9/L, and hemoglobin count ≥ 90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 14 days prior to laboratory examination); Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver invasion); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver invasion); Heart function and disease meet one of the following conditions: [see cardiac_details]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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