Actively Recruiting
Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma
Led by Sun Yat-sen University · Updated on 2025-05-31
29
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years at informed consent, any gender
- ECOG performance status between 0 and 2
- Histologically confirmed advanced or metastatic Ewing sarcoma with at least one measurable lesion not treated locally
- Tumors not amenable to complete surgical or local treatment; disease progressed after first-line chemotherapy (VAC/IE) or patient refuses local treatment
- Expected survival of at least 12 weeks
- Adequate organ function including blood counts, liver, kidney, coagulation, thyroid function, and heart function (LVEF 6%)
- Non-surgically sterile or premenopausal females must use medically approved contraception during and 6 months after treatment; males with partners of childbearing potential must also use effective contraception
- Ability to understand study procedures, voluntarily agree to participate, and sign informed consent
You will not qualify if you...
- Plans to receive other anti-tumor treatments during the trial
- Radiotherapy within 4 weeks prior to study drug or receipt of other investigational drugs or cell therapies
- Presence of intracranial tumors
- History of other active malignancies within 5 years except certain treated localized cancers
- Symptomatic ascites requiring drainage or uncontrolled pleural/pericardial effusion
- History of epilepsy or seizure-inducing diseases within 12 months prior to treatment
- Previous treatment with PARP inhibitors, irinotecan, temozolomide, or fluzoparib
- Severe allergies or intolerances to study drugs or excipients
- Severe infections or active pulmonary inflammation requiring antibiotics within 4 weeks prior to treatment
- Inability to stop medications affecting P-glycoprotein during study
- Use of strong/moderate CYP3A4 enzyme modifiers within 14 days prior to treatment
- Conditions impairing swallowing, absorption, or chronic diarrhea
- History of myelodysplastic syndromes or acute myeloid leukemia
- Co-infection with hepatitis C, HIV, hepatitis B, or syphilis
- Immune deficiency or history of organ transplantation
- History of substance abuse or alcoholism
- Any other condition posing significant safety risk or affecting study completion as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
J
Jin Wang, MD
CONTACT
C
Chuanghzong Deng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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