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Ewing SarcomaPhase 2NCT06827717

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

A Phase 2 study testing irinotecan liposome (II) + temozolomide + fluzoparib in people with Ewing Sarcoma, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ewing Sarcoma
What is being tested?
irinotecan liposome (II) + temozolomide + fluzoparib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
15 Apr 2025to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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 advanced or metastatic Ewing sarcoma, with at least one measurable lesion that has not been treated locally (according to RECIST v1.1, this measurable lesion must have a maximum diameter of ≥ 10 mm on spiral CT scans or a short diameter of ≥ 15 mm for enlarged lymph nodes).
  • 4. The primary tumor or locally recurrent tumor cannot be completely resected through surgery or other local treatments (e.g., stereotactic radiosurgery, argon-helium knife, ultrasound-guided focused ultrasound, etc.); first-line chemotherapy (VAC/IE) has failed, leading to distant metastasis, and the metastatic tumors cannot be completely resected through surgery or other local treatments; or the patient refuses surgery or other local treatments.
  • 5. Expected survival of ≥ 12 weeks. 6. Basic normal function of major organs, with severe abnormalities in blood, heart, lung, liver, kidney, bone marrow functions, or immune deficiency diseases meeting protocol requirements:
  • 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;
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  • 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 within the expected therapeutic range, can be screened);
  • 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, contraceptive pills, or condoms) during the study treatment period and for 6 months after the end of study treatment; non-surgically sterile premenopausal females must have a negative serum or urine HCG test within 7 days prior to study enrollment and must not be breastfeeding; male patients with female partners of childbearing potential should use effective contraception during the study and for 6 months after the last dose of fluzoparib, liposomal irinotecan, or temozolomide.
  • 8. Understanding the study procedures and methods, voluntarily participating in this trial, and signing the informed consent form in writing, with a full understanding of the trial content, process, and potential adverse reactions.

Who cannot join

  • 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 drugs or cell therapies.
  • 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 treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate in situ carcinoma, cervical in situ carcinoma, and breast in situ carcinoma, are allowed.
  • 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 clinical symptoms are excluded; uncontrolled or moderate to severe pleural effusion or pericardial effusion; evidence of intraperitoneal free air that cannot be explained by paracentesis or recent surgical procedures.
  • 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 trauma with loss of consciousness requiring hospitalization) within 12 months prior to the first administration of the study drug.
  • 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.
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  • 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; baseline chest imaging indicating active pulmonary inflammation, presence of infection symptoms and signs within 2 weeks before the first administration of the study drug, or requiring oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics).
  • 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 in situ cancers and malignancies determined by the investigator to have slow progression).
  • 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 disease, and psychiatric disorders) or any other situation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Wang, MD contact

86+020-87343190

wangjinr@sysucc.org.cn

Chuanghzong Deng, MD contact

86+020-87340519

dengchzh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    dengchzh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the 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:

  1. 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:

  1. 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:

  1. 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:

  1. 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
Being tested
irinotecan liposome (II) + temozolomide + fluzoparib
Keywords
Ewing sarcoma, irinotecan liposome, temozolomide, fluzoparib, PARP
Medical subject headings
Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • irinotecan liposome (II) + temozolomide + fluzoparibDrug

    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 groups in NCT06827717
Study groupRoleWhat they receive
irinotecan liposome (II) + temozolomide + fluzoparibExperimentalirinotecan liposome (II) combined with temozolomide and fluzoparib
Receives: Drug: irinotecan liposome (II) + temozolomide + fluzoparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate(ORR)

    Objective Response Rate(CR+PR), defined as best overall response (complete or partial response) across all assessment time points, determined using RECIST v1.1 criteria.

    Measured: From Cycle 1 Day 1 (C1D1) to treatment discontinuation for any reason, average of 4 months

Secondary outcomes (5)

  1. Disease Control Rate （DCR）

    Percentage of patients whose BOR is assessed as CR, PR, or Stable Disease (SD)

    Measured: From Cycle 1 Day 1 (C1D1) to treatment discontinuation for any reason, average of 4 months

  2. Duration of Response （DoR）

    The time between the date of the radiological evaluation that first confirmed CR or PR and the date of the radiation evaluation that first confirmed Progressive Disease (PD)

    Measured: From first confirmed CR or PR to confirmed PD, average of 4 months

  3. Progression Free Survival (PFS)

    Time from C1D1 until the date of objective PD (as assessed by RECIST v1.1) or the date of death (by any cause in the absence of disease progression)

    Measured: From Cycle 1 Day 1 (C1D1) to first documented objective PD or death if PD does not occur, average of 4 months

  4. Overall Survival (OS)

    Time from C1D1 until the date of death by any cause. Patients who are still alive at the time of the analysis, or who have become lost to follow-up or withdrawn consent will be censored at their last date known to be alive

    Measured: From Cycle 1 Day 1 (C1D1) to death from any cause, average of 12 months

  5. Incidence of Adverse Events [safety and tolerability]

    Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0

    Measured: From Cycle 1 Day 1 (C1D1) to 30 days after the last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start15 Apr 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827717
Sponsor's protocol ID
B2024-859-01
Status last verified
May 2025
First submitted
10 Feb 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan liposome (II) + temozolomide + fluzoparib in people with Ewing Sarcoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Wang, MD (86+020-87343190, wangjinr@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06827717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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