NCT06340204

Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ewing Sarcoma

Interventions

Type	Name	Description
DRUG	Irinotecan Hydrochloride Liposome Injection	Irinotecan Hydrochloride Liposome Injection is given weekly by 5 doses every 6 weeks (5/6 qw).

Timeline

• Start date: 2024-03-25
• Primary completion: 2026-03-25
• Completion: 2026-12-25
• First posted: 2024-04-01
• Last updated: 2024-04-03

Locations

3 sites across 1 country: China