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New treatment option for Ewing Sarcoma
Official title Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma
ClinicalTrials.gov ID: NCT06827717
What this study is testing
What is irinotecan liposome (II) + temozolomide + fluzoparib?
irinotecan liposome (II) + temozolomide + fluzoparib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ewing sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- -1. Patients aged 18 to 75 years (calculated as of the date of signing the informed consent), regardless of gender. 2\. Eastern Cooperative Oncology...
- Complete Blood Count (CBC): (No blood transfusion, use of Granulocyte-Colony Stimulating Factor [G-CSF], or corrective therapy within 14 days prior...
- Neutrophil count ≥ 1.5 × 10\^9/L;
- Platelet count ≥ 75 × 10\^9/L;
- Biochemical Tests: (No albumin infusion within 14 days)
You likely can't join if
- 1\. Plans to receive any other anti-tumor treatments during this trial. 2. Received radiotherapy for Ewing sarcoma within 4 weeks prior to the first...
- 3\. Presence of intracranial tumor lesions diagnosed by imaging. 4. History of other active malignancies within the past 5 years, or currently having...
- 5\. Presence of clinically symptomatic ascites requiring paracentesis or drainage, or having undergone paracentesis within the last 3 months; only...
- 6\. History of epilepsy, or having experienced diseases that can induce seizures (including transient ischemic attacks, strokes-not just isolated...
- 7\. Previous treatment with PARP inhibitors, irinotecan, temozolomide, including but not limited to fluzoparib.
- 8\. History of allergic reactions, including severe drug allergies or drug hypersensitivity; known allergies or intolerances to fluzoparib, liposomal...
See the full eligibility criteria
- -1. Patients aged 18 to 75 years (calculated as of the date of signing the informed consent), regardless of gender. 2\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. Histologically confirmed...
- Complete Blood Count (CBC): (No blood transfusion, use of Granulocyte-Colony Stimulating Factor [G-CSF], or corrective therapy within 14 days prior to screening) \- Hemoglobin ≥ 90 g/L;
- Neutrophil count ≥ 1.5 × 10\^9/L;
- Platelet count ≥ 75 × 10\^9/L;
- Biochemical Tests: (No albumin infusion within 14 days)
- Albumin ≥ 29 g/L;
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN);
- Total bilirubin (TBIL) ≤ 1.5 times ULN;
- Creatinine (Cr) ≤ 1.5 times ULN or Cr clearance \> 50 mL/min (Cockcroft-Gault formula):
- Male: Cr clearance = ((140 - age) × weight) / (72 × blood Cr)
- Female: Cr clearance = ((140 - age) × weight) / (72 × blood Cr) × 0.85
- Weight in kg; blood Cr in mg/mL;
- Urinary protein \< 2+ (if urinary protein ≥ 2+, a 24-hour urine protein quantification can be performed, with \< 1.0 g in 24 hours allowing for inclusion);
- Coagulation Function: Activated partial thromboplastin time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN (patients on stable doses of anticoagulants like low molecular weight heparin or warfarin, with INR...
- Thyroid Function: Thyroid-Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be evaluated, with normal levels allowing for inclusion;
- Echocardiogram: Left ventricular ejection fraction (LVEF) ≥ 60%. 7. Non-surgically sterile or premenopausal female patients must use a medically approved contraceptive method (such as an intrauterine device...
- 1\. Plans to receive any other anti-tumor treatments during this trial. 2. Received radiotherapy for Ewing sarcoma within 4 weeks prior to the first administration of the study drug, or received other investigational...
- 3\. Presence of intracranial tumor lesions diagnosed by imaging. 4. History of other active malignancies within the past 5 years, or currently having other active malignancies aside from Ewing sarcoma. Curatively...
- 5\. Presence of clinically symptomatic ascites requiring paracentesis or drainage, or having undergone paracentesis within the last 3 months; only those with small amounts of ascites detected by imaging but without...
- 6\. History of epilepsy, or having experienced diseases that can induce seizures (including transient ischemic attacks, strokes-not just isolated imaging findings of cerebral ischemia without clinical history, or head...
- 7\. Previous treatment with PARP inhibitors, irinotecan, temozolomide, including but not limited to fluzoparib.
- 8\. History of allergic reactions, including severe drug allergies or drug hypersensitivity; known allergies or intolerances to fluzoparib, liposomal irinotecan, temozolomide, or their excipients.
- 9\. Severe infections (CTCAE grade \> 2) occurring within 4 weeks prior to the first administration of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infections with complications...
- 10\. Cannot discontinue the use of medications that may affect P-glycoprotein (P-gp) during the study period.
- 11\. Use of strong or moderate inhibitors or inducers of hepatic drug-metabolizing enzyme CYP3A4 within 14 days prior to the first administration of the study drug.
- 12\. Presence of factors that impair swallowing, chronic diarrhea, bowel obstruction, or other factors affecting drug intake and absorption.
- 13\. History of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or having had other malignancies within 5 years prior to the first administration of this study (with the exception of completely resolved...
- 14\. Co-infection with other viral infections (anti-HCV positive, anti-HIV positive, HBsAg positive) or syphilis infection.
- 15\. History of immune deficiency (including positive human immunodeficiency virus [HIV] test, other acquired or congenital immune deficiencies) or history of organ transplantation.
- 16\. Known history of abuse of psychotropic substances, alcoholism, or drug abuse.
- 17\. Any condition judged by the investigator to pose a significant risk to patient safety or to affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, thyroid...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.