RecruitingPhase 1NCT06340204

Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma


Sponsor

Peking University People's Hospital

Enrollment

44 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 8 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new formulation of irinotecan (a chemotherapy drug) delivered in tiny fat-based particles called liposomes — given weekly — for patients with Ewing sarcoma (a bone and soft tissue cancer) that has come back or stopped responding to standard treatments. **You may be eligible if...** - You have been diagnosed with Ewing sarcoma, confirmed by biopsy and genetic testing - Your cancer has relapsed or is no longer responding to standard treatment - You have previously received standard Ewing sarcoma chemotherapy (doxorubicin, vincristine, cyclophosphamide, ifosfamide, etoposide) - Your cancer is measurable on CT or MRI scans - Your overall health is good enough (ECOG 0–1) and organs are functioning adequately - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have active, uncontrolled brain or spinal cord metastases currently requiring steroids - Your prior treatment was completed less than 3 weeks ago (less than 2 weeks for radiation) - You have significant organ dysfunction that hasn't recovered Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIrinotecan Hydrochloride Liposome Injection

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


Locations(3)

Shandong Cancer Hospital and Institute

Jina, Shandong, China

Peking University People's Hospital

Beijin, China

Peking University Shougang Hospital

Beijing, China

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NCT06340204


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