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.
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:
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- 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.
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 group | Role | What they receive |
|---|---|---|
| Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) | Experimental | Not described Receives: Drug: Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) |
| Irinotecan Combined with Temozolomide and Vincristine (VIT) | Active comparator | Not 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.
Objective Response Rate,ORR
Measured: 6 weeks
Secondary outcomes (2)
progression free survival,PFS
Measured: 1 year
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.
- First posted29 Jul 2025
- Study start10 Aug 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing's SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tang Xiaodong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tang Xiaodong, Peking University People's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07092306
- Acronym / sponsor ID
- 2025PHD002-001
- Conditions
- Ewing's Sarcoma
- Keywords
- Irinotecan Hydrochloride Liposome Injection, NALIRI-VT, Temozolomide, Vincristine, Ewing's Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Tang XiaodongUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) | Experimental | Drug: Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) |
| Irinotecan Combined with Temozolomide and Vincristine (VIT) | Active comparator | Drug: Irinotecan Combined with Temozolomide and Vincristine (VIT) |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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.
- 1) Blood routine examination must meet the following criteria (no blood transfusion, no use of hematopoietic factors, and no drug correction within 14 days):
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT)(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; | Drug | Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT) |
| Irinotecan Combined with Temozolomide and Vincristine (VIT)(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; | Drug | Irinotecan Combined with Temozolomide and Vincristine (VIT) |
Primary outcome
Objective Response Rate,ORR
Time frame: 6 weeks
2 secondary outcomes
progression free survival,PFS
Time frame: 1 year
overall survival,OS
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.