NCT06827717

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-center, single-arm, phase II study evaluating the efficacy and safety of irinotecan liposome (II) combined with temozolomide and fluzoparib in the treatment of recurrent or metastatic ewing sarcoma which progressed on 1st line chemotherapy. Eligible patients will be included in this study and treated according to the protocol. Study treatment will be continued until disease progression, unacceptable toxicity, or patient's decision/consent withdrawal. Local investigators will determine disease progression, radiologic or clinical deterioration. A Simon Two-Stage design will enroll approximately 13 patients into Stage 1, and if criteria are met to move to Stage 2, an additional 16 patients will be enrolled. PRIMARY OBJECTIVE: I. To assess the antineoplastic efficacy of irinotecan liposome (II) combined with temozolomide and fluzoparib in the treatment of recurrent or metastatic Ewing sarcoma, as measured by the objective response rate (ORR). SECONDARY EFFICACY OBJECTIVES: I. To determine the disease control rate (DCR) for irinotecan liposome (II) combined with temozolomide and fluzoparib in the treatment of recurrent or metastatic Ewing sarcoma. II. To calculate the duration of response (DOR) for irinotecan liposome (II) combined with temozolomide and fluzoparib in the treatment of recurrent or metastatic Ewing sarcoma. III. To measure median progression-free survival (PFS) in recurrent or metastatic Ewing sarcoma patients who have received irinotecan liposome (II) combined with temozolomide and fluzoparib. VI. To measure median overall survival (OS) in recurrent or metastatic Ewing sarcoma patients who have received irinotecan liposome (II) combined with temozolomide and fluzoparib. SECONDARY SAFETY OBJECTIVE: I. To assess the toxicity profile of irinotecan liposome (II) combined with temozolomide and fluzoparib in the treatment of recurrent or metastatic Ewing sarcoma according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Exploratory OBJECTIVE: I. To explore the relationship between mutations and expression of DNA Homologous Recombination Repair (HRR) related genes (such as BRCA1/2, PALB2, etc.) and clinical efficacy (such as ORR, DoR, etc.), as well as resistance mechanisms.

Conditions

• Ewing Sarcoma

Interventions

Type	Name	Description
DRUG	irinotecan 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.

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-04-01
• Completion: 2028-02-01
• First posted: 2025-02-14
• Last updated: 2025-05-31

Locations

1 site across 1 country: China