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Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:
The Therapeutic Effect of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Platinum Sensitive Recurrent Small Cell Lung Cancer

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06467786
Study type Interventional
Source Tang-Du Hospital
Contact Haichuan Su, PhD
Phone 18629190366
Email such@fmmu.edu.cn
Status Recruiting
Phase Phase 4
Start date March 15, 2024
Completion date September 15, 2028
View Details
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