Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma

Status Recruiting

Clinical Trial Summary

The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.

Clinical Trial Description

After standard multimodal therapy, the prognosis of relapsed and metastatic Ewing Sarcoma is dismal and unchanged over the last decades. The anti-tumor activity of irinotecan was demonstrated by several studies in the past. However, longer schedule of irinotecan infusion (traditionally dx5x2) has impacted quality of life in these patients. The irinotecan liposomes may be more active than the parent compound irinotecan since its ability to stay longer in circulation system, and much more convenient to given weekly. Thus, the investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma after the failure of first-line chemotherapy with doxorubicin, vincristine, cyclophosphamide, ifosphamide and etoposide. Bayesian Optimal Interval (BOIN) design is adopted in this dose-finding study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06340204
Study type	Interventional
Source	Peking University People's Hospital
Contact
Status	Recruiting
Phase	Phase 1
Start date	March 25, 2024
Completion date	December 25, 2026

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