RecruitingPhase 2NCT06827717

Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma

Single-center, Single-arm, Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in the Treatment of Recurrent or Metastatic Ewing Sarcoma

Sponsor

Sun Yat-sen University

Enrollment

29 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Ewing Sarcoma

Summary

The current study is an investigator-initiated, single-arm phase 2 study that enrolled patients with recurrent and/or metastatic Ewing sarcoma for the treatment of Irinotecan Liposome (II) Combined with Temozolomide and Fluzoparib as the second-line treatment.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — irinotecan liposome, temozolomide, and fluzoparib — for people with Ewing sarcoma (a type of bone or soft tissue cancer) that has come back or spread after prior treatment. **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with advanced or metastatic Ewing sarcoma confirmed by biopsy - Your cancer has at least one measurable tumor on a scan - Your tumor cannot be fully removed by surgery - You have received prior treatment that is no longer working - You are in reasonably good physical condition (ECOG score 0–2) **You may NOT be eligible if...** - Your cancer has not been previously treated (this is for relapsed or refractory disease) - You have serious organ problems (heart, liver, kidney, or blood cell abnormalities) - You have another cancer type mixed in with the Ewing sarcoma (with certain exceptions) - You are pregnant or breastfeeding 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 liposome (II) + temozolomide + fluzoparib

Drug Irinotecan Hydrochloride Liposome Injection（II）56.5mg/m2, IV infusion administered on day 1 of every 28-day cycle until disease progression, unacceptable toxicity or death. Other names: HR070803. Drug Fluzoparib 50mg PO bid, administered continuously until disease progression, unacceptable toxicity or death. 28 days as a treatment cycle. Other names: SHR-3162. Drug Temozolomide 30mg/m2 PO qd, administered on day 1 to day 5 of every 28-day cycle until disease progression, unacceptable toxicity or death.

Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06827717

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