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

Sponsor
Sun Yat-sen University
Study ID
NCT06827717
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • irinotecan liposome (II) + temozolomide + fluzoparib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 15, 2025
Status verified
May 2025
Primary completion
Apr 30, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan liposome (II) + temozolomide + fluzoparib
    irinotecan liposome (II) combined with temozolomide and fluzoparib

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: From Cycle 1 Day 1 (C1D1) to treatment discontinuation for any reason, average of 4 months ]

Central Contacts

Related Studies