OncoMatch/Clinical Trials/NCT06827717

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

Is NCT06827717 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies irinotecan liposome (II) + temozolomide + fluzoparib for ewing sarcoma.

Phase 2RecruitingSun Yat-sen UniversityNCT06827717Data as of May 2026

Treatment: irinotecan liposome (II) + temozolomide + fluzoparib — 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Disease stage

Required: Stage IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: VAC/IE chemotherapy — first-line

first-line chemotherapy (VAC/IE) has failed, leading to distant metastasis

Cannot have received: PARP inhibitor (fluzoparib)

Previous treatment with PARP inhibitors, including but not limited to fluzoparib

Cannot have received: topoisomerase I inhibitor (irinotecan)

Previous treatment with irinotecan

Cannot have received: alkylating agent (temozolomide)

Previous treatment with temozolomide

Lab requirements

Blood counts

Hemoglobin ≥ 90 g/L; Neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 75 × 10^9/L

Kidney function

Creatinine ≤ 1.5x ULN or Cr clearance > 50 mL/min

Liver function

ALT and AST ≤ 2.5x ULN; TBIL ≤ 1.5x ULN

Cardiac function

LVEF ≥ 60%

Basic normal function of major organs... see protocol for details

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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