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AzTrials

Ewing's SarcomaPhase 2NCT07092306

A Randomized Controlled Study Comparing the Safety and Efficacy of Irinotecan Hydrochloride Liposome Injection Combined With Temozolomide and Vincristine (NALIRI-VT) Versus Irinotecan Combined With Temozolomide and Vincristine (VIT) in Patients With Advanced Ewing's Sarcoma

A Phase 2 study testing Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) and Irinotecan Combined with Temozolomide and Vincristine (VIT) in people with Ewing's Sarcoma, run by Tang Xiaodong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a randomized, controlled, multicenter, prospective clinical trial with a planned enrollment of 74 patients, who will be randomly assigned in a 2:1 ratio. After enrollment, patients will receive either irinotecan liposomal injection combined with temozolomide and vincristine or irinotecan injection… Read more about this study

Who is it for?
Ages 8 to 40 years
Conditions the study is for
Ewing's Sarcoma
What is being tested?
Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) and Irinotecan Combined with Temozolomide and Vincristine (VIT)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
No sites listed yet
Study dates
10 Aug 2025to 1 May 2027
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 8 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 1. The subject or their legal representative must sign the written informed consent before enrollment.
  • 2. Age ≥ 8 years and ≤ 40 years, both male and female are eligible. 3. Pathologically confirmed Ewing's sarcoma, and detailed pathological reports must be provided. Pathology must be confirmed by fluorescence in situ hybridization (FISH) or next-generation sequencing (NGS) to show the presence of Ewing's sarcoma-specific FET family (including EWSR1 or FUS) gene breaks. This study does not impose special restrictions on fusion partner genes, but clear FET-non ETS fusions (such as EWSR1-WT1, EWSR1-NFATC2, EWSR1-PATZ1, etc.) do not meet the enrollment criteria.
  • 4. At least one measurable target lesion as judged by RECIST 1.1 criteria. 5. Failure of first-line standard treatment. First-line standard treatment includes the following drugs: doxorubicin, cyclophosphamide and/or ifosfamide. Treatment failure is defined as disease progression during adjuvant chemotherapy or within 6 months after chemotherapy. For disease progression more than 6 months after chemotherapy, the consent of the subject or their legal representative is required.
  • 6. ECOG score: 0-1. 7. Expected survival ≥ 3 months. 8. Recovery from previous treatment: According to NCI-CTCAE 5.0, all side effects (except alopecia) must have subsided to grade 1 or below.
  • 9. Normal major organ function, meeting the following criteria:
  • 1) Blood routine examination must meet the following criteria (no blood transfusion, no use of hematopoietic factors, and no drug correction within 14 days):
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  • ANC ≥ 1.5×109/L;
  • HB ≥ 90 g/L;
  • PLT ≥ 100×109/L; 2) Biochemical examination must meet the following criteria:
  • <!-- -->
  • TBIL ≤ 1.5 ULN;
  • ALT, AST ≤ 2.5 ULN (if liver function abnormalities are due to liver metastasis, then ≤ 5 ULN);
  • Serum creatinine sCr ≤ 1.5 ULN, endogenous creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula); 3) Coagulation function must meet the following criteria: INR ≤ 1.5 and APTT ≤ 1.5 ULN.
  • 10. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within one week before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization.

Who cannot join

  • 1. Known hypersensitivity, anaphylaxis or intolerance to irinotecan liposome, temozolomide and vincristine or their excipients; 2. Within 2 weeks after the last systemic cytotoxic drug treatment, radiotherapy, targeted therapy or any anti-tumor drug treatment except immunotherapy; 3. Patients who have received irinotecan treatment before; 4. Other malignant tumors within the past 5 years; 5. Known symptomatic central nervous system metastases; 6. Known symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or unstable brain or leptomeningeal disease found on CT or MRI at screening; 7. Symptomatic serous cavity effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical intervention; 8. Uncontrolled concomitant diseases, including but not limited to: poorly controlled hypertension, heart failure, diabetes, persistent active infection, poorly controlled active peptic ulcer, or mental disorders or social conditions that may affect the subject's compliance with the study; 9. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4s or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 10. Treatment with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; Note: Under the condition of INR ≤ 1.5, low-dose heparin (adult daily dose of 6,000 - 12,000 U), low-dose aspirin (daily dose ≤ 100 mg), or rivaroxaban (daily dose ≤ 10 mg) for preventive purposes is allowed; 12. History of drug abuse of psychotropic drugs and unable to quit or with mental disorders; 13. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 14. Open wounds, fractures, or poorly healing wounds; 15. Major surgery within 2 weeks; 16. Confirmed inflammatory bowel disease, intestinal obstruction or chronic diarrhea; 17. Cavity organ fistula or perforation within 6 months; 18. Active hepatitis B or C virus infection or active infection requiring antimicrobial treatment (such as the use of antibacterial drugs, antiviral drugs, antifungal drugs); 19. Participation in other interventional anti-tumor clinical trials within 4 weeks; 20. Patients who have used strong CYP3A4 inducers or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 3 weeks before the first dose; 21. Lactation; 22. Any condition that the investigator deems may harm the patient or prevent the patient from meeting or fulfilling the study requirements.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Tang Xiaodong contact

010-88326196

tang15877@126.com

About this study

This study is a randomized, controlled, multicenter, prospective clinical trial with a planned enrollment of 74 patients, who will be randomly assigned in a 2:1 ratio. After enrollment, patients will receive either irinotecan liposomal injection combined with temozolomide and vincristine or irinotecan injection combined with temozolomide and vincristine. The aim is to evaluate the efficacy, safety, and impact on quality of life of the irinotecan liposomal combination regimen compared to the irinotecan injection combined with temozolomide and vincristine in the treatment of advanced Ewing's sarcoma.

Conditions
Ewing's Sarcoma
Being tested
Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT), Irinotecan Combined with Temozolomide and Vincristine (VIT)
Keywords
Irinotecan Hydrochloride Liposome Injection, NALIRI-VT, Temozolomide, Vincristine, Ewing's Sarcoma
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 Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT)Drug

    (NALIRI-VT,Nanoliposomal Irinotecan,Vincristine,Temozolomide), Nanoliposomal Irinotecan:35 mg/m2/d,iv,D1,8,15, Temozolomide:100 mg/m2/d,po,D1-5, Vincristine:1.4 mg/m2/d,iv,D1,最大剂量2mg;

  • Irinotecan Combined with Temozolomide and Vincristine (VIT)Drug

    (VIT,Vincristine,Irinotecan,Temozolomide) Irinotecan:50 mg/m2/d,iv,D1-5, Temozolomide:100 mg/m2/d,po,D1-5, Vincristine:1.4 mg/m2/d,iv,D1,最大剂量2mg;

Study groups in NCT07092306
Study groupRoleWhat they receive
Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT)ExperimentalNot described
Receives: Drug: Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT)
Irinotecan Combined with Temozolomide and Vincristine (VIT)Active comparatorNot described
Receives: Drug: Irinotecan Combined with Temozolomide and Vincristine (VIT)

What is being measured

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

  1. Objective Response Rate,ORR

    Measured: 6 weeks

Secondary outcomes (2)
  1. progression free survival,PFS

    Measured: 1 year

  2. overall survival,OS

    Measured: 1 year

Timeline

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

  1. First posted29 Jul 2025
  2. Study start10 Aug 2025 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092306
Sponsor's protocol ID
2025PHD002-001
Status last verified
Jul 2025
First submitted
29 Jun 2025
Last updated
29 Jul 2025
Results posted
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 Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) and Irinotecan Combined with Temozolomide and Vincristine (VIT) in people with Ewing's Sarcoma, run by Tang Xiaodong.

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 14 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Tang Xiaodong (010-88326196, tang15877@126.com), 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: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Jul 2025.

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