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.
Based on literature research and the birth of independently developed irinotecan liposomes by Shiyao, we plan to conduct a therapeutic study on the combination of irinotecan liposomes and cisplatin/carboplatin for platinum sensitive recurrent small cell lung cancer. The aim is to explore the efficacy and safety of the combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line treatment of small cell lung cancer patients who have progressed after 6 months using platinum based regimens, providing better clinical evidence for use. The research unit is the Second Affiliated Hospital of Air Force Military Medical University. The study includes screening period (within 28 days), treatment period, and follow-up period (safety follow-up and PFS follow-up). The subjects signed an informed consent form and underwent baseline examination during the screening period. Patients who met the inclusion and exclusion criteria entered the treatment period. All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety, tolerance, and efficacy. The same subject only received one dosing plan during the study period. After the treatment period ends, enter the follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Irinotecan hydrochloride liposome injection combined with platinum
Tangdu Hospital
Xi'an, Shannxi, China
RECRUITINGIntracranial Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Progression-free survival
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years
Duration of Response
Duration of Response(DoR)refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death
Time frame: Duration of Response(DoR)analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years
Overall Survival
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).
Time frame: The maximum time from receiving treatment to dying for any reason is 4 years.
Safety/Adverse event
Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.
Time frame: From the first recorded chemotherapy to 4 weeks after the last recorded chemotherapy
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