Soft Tissue Sarcoma (Excluding GIST)Phase 2NCT07457775
Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS
A Phase 2 study testing Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma in people with Soft Tissue Sarcoma (Excluding GIST), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The study is expected to include 24 patients with metastatic or surgically unresectable relapsed/refractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Soft Tissue Sarcoma (Excluding GIST)
- What is being tested?
- Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Jan 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥14 years old, gender not limited;
- For metastatic or surgically unresectable recurrent and refractory soft tissue sarcomas confirmed by histological evidence, this combination therapy regimen can be used as determined by the researcher.
- Disease progression or intolerable toxicity has occurred after at least one line of systemic therapy (with or without targeted therapy) in the past.
- At least one measurable lesion (RECIST v1.1);
- ECOG: 0-2;
- Expected survival period ≥3 months;
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- Good function of major organs, that is, meeting the following criteria (without receiving any blood components or cell growth factors within 14 days prior to randomization) :
- Neutrophils ≥1.5109/L; Platelet count ≥80109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl; (2) Total bilirubin ≤ 1.5 times the upper limit of the normal value (biliary drainage is allowed for biliary obstruction); ALT and AST≤ 3 times the upper limit of the normal value (for patients with liver metastasis, it can be relaxed to ≤ 5 times the upper limit of the normal value).
- Serum creatinine ≤ 1.5 times the upper limit of the normal value, creatinine clearance rate ≥60ml/min; (4) INR≤ 1.5 times the upper limit of the normal value and APTT≤ 1.5 times the upper limit of the normal value (screening can be conducted for anticoagulant therapy with stable doses such as low-molecular-weight heparin or warfarin and INR within the expected therapeutic range of the anticoagulant); (5) Electrocardiogram: QTcF≤450ms(for males), ≤470ms(for females); (6) Cardiac color Doppler ultrasound: LVEF (left ventricular ejection fraction) ≥50%; Women of childbearing age must undergo a blood pregnancy test within 3 days before randomization, and the result must be negative. They must also be willing to take appropriate contraceptive measures during the trial and for 6 months after the end of treatment. For men, it should be agreed to use appropriate methods of contraception during the study period and within 3 months after the end of treatment; 9. The subjects voluntarily joined this study and signed the informed consent form.
Who cannot join
- Patients with known central nervous system metastases;
- Severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation above grade 2; diarrhea above grade 1);
- Patients who have a history of treatment with irinotecan, temozolomide, bevacizumab or similar drugs;
- Within the two weeks prior to randomization, there was third space effusion (such as a large amount of pleural effusion) that could not reach a stable state except for ascites (no intervention treatment is required after the drainage tube is removed);
- Patients with ascites with clinical symptoms who require puncture or drainage, or those who have received ascites drainage within the past 3 months (except for those with only a small amount of ascites shown on imaging and controllable, but without clinical symptoms);
- Currently accompanied by interstitial pneumonia or interstitial lung disease, or those with a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy in the past, or other conditions that may interfere with the judgment and management of immune-related lung toxicity such as pulmonary fibrosis or organizing pneumonia (for example, Subjects with obliterative bronchiolitis, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or those with active pneumonia or severely impaired lung function as shown by chest CT during the screening period; Active tuberculosis
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- Subjects with active autoimmune diseases or a history of autoimmune diseases that may relapse [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (subjects that can be controlled only through hormone replacement therapy can be enrolled)]; Those with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes treated with insulin, or childhood asthma that has been completely relieved and does not require any intervention in adulthood can be enrolled.
- Known peripheral neuropathy (CTCAE≥ grade 3);
- Known dihydropyrimidine dehydrogenase (low activity) or deficiency;
- Severe infections (CTCAE > grade 2) occurred within 4 weeks prior to randomization, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. There were symptoms and signs of infection within 2 weeks prior to randomization, requiring intravenous antibiotic treatment (except for prophylactic antibiotic use).
- Have received any of the following treatments:
- The concomitant medication contained CYP3A4, CYP2C8 strong suppressor/strong inducer or UGT1A1 strong suppressor within 2 weeks prior to randomization; Use immunosuppressants or systemic hormones for immunosuppressive purposes within 2 weeks before randomization (dose >10mg/ day, prednisone or other equivalent therapeutic hormones); <s:1> Received radiotherapy within 2 weeks prior to randomization; Undergo major surgeries (such as thoracotomy, laparotomy, etc.) within 4 weeks before randomization; The patient has received any other clinical study drug treatment within 4 weeks prior to randomization, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study.
- Abnormal coagulation function, with a bleeding tendency, or currently undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg/ day) and low-molecular-weight heparin (enoxaparin 40mg/ day and other low-molecular-weight heparin at equivalent doses) is permitted.
- There are poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Has suffered a myocardial infarction within six months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias who require treatment or intervention;
- Within the 3 years prior to randomization, the patient had a malignant tumor other than relapsed or refractory soft tissue sarcoma, excluding well-treated carcinoma in situ, cutaneous basal cell or squamous cell carcinoma, etc., which showed no signs of recurrence.
- Individuals who are known to be allergic to irinotecan liposomes, other liposome products, temozolomide, bevacizumab, or any of the components in the above products;
- Those who are known to have acquired immune deficiency syndrome (AIDS) or test positive for HIV, or are active syphilis carriers;
- There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia;
- As determined by the researchers, the subjects have other factors that may force them to terminate the study halfway, such as non-compliance with the protocol, suffering from other serious diseases (including mental disorders) that require concurrent treatment, having severely abnormal laboratory test values of clinical significance, family or social factors that may affect the safety of the subjects or the collection of trial data, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
Ying Dong, 0571-56978177, dongying74@edu.cn
About this study
Official title: A Study of Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Relapsed or Refractory Soft Tissue Sarcoma
The study is expected to include 24 patients with metastatic or surgically unresectable relapsed/refractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. The efficacy and safety of liposome irinotecan combined with temozolomide and bevacizumab in the treatment of relapsed/refractory soft tissue sarcoma will be evaluated.
- Conditions
- Soft Tissue Sarcoma (Excluding GIST)
- Being tested
- Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizumaDrug
Irinotecan Hydrochloride Liposome Injection(II) : 56.5 mg/m2, intravenous infusion for 90 minutes (+30 minutes), day 1, 3 weeks as one study cycle; Clotemozolomide: 100 mg/m2/day × 5 days, with 3 weeks as one study cycle; Bevacizumab: 7.5 mg/kg, intravenous infusion, 1 day, 3 weeks as one study cycle.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan Hydrochloride Liposome Injection（II） combined with temozolomide and bevacizumab | Experimental | Not described Receives: Drug: Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) is a measure used in clinical trials and medical research to evaluate the effectiveness of treatments, especially in oncology. It refers to the length of time during and after treatment that a patient lives with a disease without it getting worse. In other words, PFS is the duration from the start of treatment until the disease progresses or until the patient dies from any caus，whichever came first, assessed up to 24 months
Measured: through study completion， assessed up to 24 months
Safety-Adverse events (AE)
Adverse events (AE)/serious adverse events (SAE) (judged based on NCI-CTCAE 5.0), etc.
Measured: through study completion，assessed up to 24 months
Secondary outcomes (5)
Objective response rate (ORR)
From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Measured: through study completion, an average of 1 year
12-week PFS rate
the percentage of patients who remain progression-free after 12 weeks treatment
Measured: 12 weeks
overall survival
From the date of enrollment until the date of death from any cause or the end of the study, whichever came first, assessed up to 24 months
Measured: through study completion, an average of 2 years
Disease Control Rate (DCR）
From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Measured: through study completion, an average of 1 year
Duration of remission (DoR）
From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (Excluding GIST)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457775
- Sponsor's protocol ID
- 2025-1631
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Relapsed or Refractory Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT07457775
- Acronym / sponsor ID
- 2025-1631
- Conditions
- Soft Tissue Sarcoma (Excluding GIST)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 Mar 2026 (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.
The study is expected to include 24 patients with metastatic or surgically unresectable relapsed/refractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. The efficacy and safety of liposome irinotecan combined with temozolomide and bevacizumab in the treatment of relapsed/refractory soft tissue sarcoma will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan Hydrochloride Liposome Injection（II） combined with temozolomide and bevacizumab | Experimental | Drug: Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥14 years old, gender not limited;
- For metastatic or surgically unresectable recurrent and refractory soft tissue sarcomas confirmed by histological evidence, this combination therapy regimen can be used as determined by the researcher.
- Disease progression or intolerable toxicity has occurred after at least one line of systemic therapy (with or without targeted therapy) in the past.
- At least one measurable lesion (RECIST v1.1);
- ECOG: 0-2;
Key exclusion criteria (19 listed)
- Patients with known central nervous system metastases;
- Severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation above grade 2; diarrhea above grade 1);
- Patients who have a history of treatment with irinotecan, temozolomide, bevacizumab or similar drugs;
- Within the two weeks prior to randomization, there was third space effusion (such as a large amount of pleural effusion) that could not reach a stable state except for ascites (no intervention treatment is required after the drainage tube is removed);
- Patients with ascites with clinical symptoms who require puncture or drainage, or those who have received ascites drainage within the past 3 months (except for those with only a small amount of ascites shown on imaging and controllable, but without clinical symptoms);
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(II) combined with temozolomide and bevacizumaIrinotecan Hydrochloride Liposome Injection(II) : 56.5 mg/m2, intravenous infusion for 90 minutes (+30 minutes), day 1, 3 weeks as one study cycle; Clotemozolomide: 100 mg/m2/day × 5 days, with 3 weeks as one study cycle; Bevacizumab: 7.5 mg/kg, intravenous infusion, 1 day, 3 weeks as one study cycle. | Drug | Irinotecan Hydrochloride Liposome Injection（II） combined with temozolomide and bevacizumab |
Primary outcome
Progression-free survival (PFS)
Time frame: through study completion， assessed up to 24 months
Progression-free survival (PFS) is a measure used in clinical trials and medical research to evaluate the effectiveness of treatments, especially in oncology. It refers to the length of time during and after treatment that a patient lives with a disease without it getting worse. In other words, PFS is the duration from the start of treatment until the disease progresses or until the patient dies from any caus，whichever came first, assessed up to 24 months
Safety-Adverse events (AE)
Time frame: through study completion，assessed up to 24 months
Adverse events (AE)/serious adverse events (SAE) (judged based on NCI-CTCAE 5.0), etc.
5 secondary outcomes
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
12-week PFS rate
Time frame: 12 weeks
overall survival
Time frame: through study completion, an average of 2 years
Disease Control Rate (DCR）
Time frame: through study completion, an average of 1 year
Duration of remission (DoR）
Time frame: through study completion, an average of 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 9 Mar 2026.
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RecruitingPhase 2
Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma in people with Soft Tissue Sarcoma (Excluding GIST), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 inclusion and 19 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 9 Mar 2026. 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 Ying Dong (56978177 ext. 0571, dongying74@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: through study completion， assessed up to 24 months). The study lists 2 primary outcomes in all. 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 9 Mar 2026.