Angiosarcoma MetastaticPhase 2NCT04859465
Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma
A Phase 2 study testing Abraxane combined with liposomal doxorubicin in people with Angiosarcoma Metastatic, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose is to explore the efficacy and safety of the combination of albumin-bound paclitaxel and liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Angiosarcoma Metastatic
- What is being tested?
- Abraxane combined with liposomal doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2021to 20 Nov 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients voluntarily participated in the study and signed the informed consent; In all advanced angiogenic sarcomas confirmed by pathology, the standard treatment failed or there was no standard treatment or the standard treatment could not be tolerated. There is at least one measurable lesion according to RECIST 1.1, mainly including angiosarcoma, epithelioid hemangioendothelioma, epitheliosarcoma hemangioendothelioma, pseudomyogenic hemangioendothelioma, Kaposi sarcoma, malignant solitary fibroma / hemangiopericytoma, malignant glomus tumor, etc.
- Patients in advanced stage with unresectable lesions or lymph node or distant metastasis by imaging evaluation;
- In the past three months, there was at least one target lesion that could be measured according to RECIST version 1.1 standard, and it could be accurately measured in at least one direction (the maximum diameter needs to be recorded) by MRI or CT, including conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.
- 18-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;
- The main organ function met the following criteria within 7 days before treatment (1) Blood routine examination standard (without blood transfusion within 14 days)
- Hemoglobin (HB) ≥ 90g / L; ② Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;
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- ③ Platelet count (PLT) ≥ 80 × 109 / L.
- Biochemical tests should meet the following standards:
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 × ULN ALT and AST ≤ 5 ×ULN in patients with liver metastasis; ③ Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60ml / min;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).
- Women of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; women with negative serum or urine pregnancy test within 7 days before the study and must be non lactation patients; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
Who cannot join
- 1) Patients who have previously received abraxane treatment.
- 2) There were other malignant tumors in the past 5 years or at the same time, except for the cured cervical carcinoma in situ, skin cancer without melanoma and superficial bladder tumor (TA (non invasive tumor), tis (in situ cancer) and T1 (tumor infiltrating basement membrane);
- 3) Systemic anti-tumor treatment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C use within 6 weeks prior to the treatment of the trial drug), is planned within 4 weeks before the group is given or during the study medication. The radiotherapy was performed within 4 weeks before the group or the limited field radiotherapy was performed within 2 weeks before the group;
- 4) With pleural effusion or ascites, respiratory syndrome (≥ CTC AE class 2 dyspnea (dyspnea 2 refers to shortness of breath when a small amount of activity is used; It can affect instrumental daily life activities);
- 5) No remission of toxic reactions caused by any previous treatment was higher than that of CTC AE (4.01), excluding hair loss and lymphocyte reduction;
- 6) Patients with any serious and / or uncontrollable diseases, including:
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- The patients with poor blood pressure control (systolic pressure ≥ 150 mmHg and diastolic pressure ≥ 100 mmHg) were found;
- Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms) and ≥ 2 congestive heart failure (NYHA classification);
- Active or uncontrollable severe infection (≥ CTC AE Level 2 infection);
- Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need to be treated with antiviral treatment;
- Renal failure requires hemodialysis or peritoneal dialysis;
- The control of diabetes mellitus was not good (FBG) was more than 10mmol/l;
- The routine urine suggested that the urine protein was ≥ + +, and the 24-hour urine protein was more than 1.0 G;
- Patients with epilepsy and need treatment;
- 7) The patients were treated with major surgery, incision biopsy or obvious traumatic injury within 28 days before entering the group;
- 8) Patients with any signs of bleeding constitution or history, regardless of severity; In the 4 weeks before entering the group, there were unconnected wounds, ulcers or fractures in patients with bleeding or bleeding events ≥ CTCAE Level 3;
- 9) The patients with arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- 10) The patients with active ulcer, perforation and obstruction of intestine;
- 11) The patients had clinical symptoms of central nervous system metastasis (such as brain edema, hormone intervention, or brain metastasis progress); Patients who have received brain or meningeal metastasis treatment before, such as clinical stability (MRI) have been maintained for at least 2 months, and patients who have stopped systemic hormone therapy (dose > 10mg / day prednisone or other therapeutic hormone) for more than 2 weeks can be included;
- 12) The subjects were using immunosuppressant, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose > 10mg / day prednisone or other therapeutic hormone), and were still in use within 2 weeks before entering the group;
- 13) The subjects had any active autoimmune disease or had a history of autoimmune disease (such as, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; If the subjects had vitiligo or had been completely relieved in childhood asthma, no intervention was needed in adult; Asthma in which the subjects needed bronchodilators to intervene in medicine could not be included;
- 14) Subjects had active tuberculosis and immunodeficiency history including human immunodeficiency virus (HIV) or other acquired or congenital immunodeficiency disease or active hepatitis (transaminase does not conform to inclusion, hepatitis B virus (HBV) DNA ≥ 104/ ml or hepatitis C virus seropositive (HCV) RNA ≥ 103/ml or higher); Chronic hepatitis B virus carriers with HBV DNA < 2000 iu/ml (< 104 / ml) must be treated with antiviral therapy throughout the study.
- 15) According to the researchers' judgment, the subjects are not suitable for entering the group or other factors may lead to the termination in the middle of the course. For example, other serious diseases (including mental diseases) need to be treated together, there are serious laboratory abnormalities, and family or social factors, which will affect the safety of the subjects, or the collection of test data and samples;
- 16) The clinical trials of other anti-tumor drugs were conducted 28 days before entering the group.
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, 1 recruiting
- Recruiting
Xing Zhang
Guangzhou, Guangdong, 510060
Xing Zhang
About this study
Official title: Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma--an Open, Single Arm, Multicenter Phase II Study
The purpose is to explore the efficacy and safety of the combination of albumin-bound paclitaxel and liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma.
Read the detailed description
Soft tissue sarcoma (STS) is a relatively rare malignant tumor. In recent years, the disease has been increasing gradually. As an important biological feature of soft tissue sarcoma is local recurrence and distant metastasis, most patients die of distant metastasis. Despite the improvement of local control rate, more than 50% of patients died of unresectable or distant metastasis due to tumor progression. Doxorubicin and ifosfamide based chemotherapy is the standard first-line treatment for patients with relapsed / distant metastasis / unresectable advanced soft tissue sarcoma. For patients who fail or cannot tolerate first-line treatment, the choice of treatment is still limited. At present, some clinical patients who failed to receive standard treatment have tried to use the albumin-bound paclitaxel and liposomal doxorubicin regimen, with the ORR of 33% and PFS of about 8 months. As a new combination of chemotherapy drugs, more targeted phase II clinical studies are needed to evaluate the efficacy and safety of the new chemotherapy drugs in a variety of cancer species. In view of the above problems, this study aims to observe and explore the efficacy and safety of the combination of albumin-bound paclitaxel (keaili) and liposomal doxorubicin (duomeisu) in the treatment of advanced angiogenic sarcoma patients, and to provide better treatment options for patients with advanced sarcoma.
- Conditions
- Angiosarcoma Metastatic
- Being tested
- Abraxane combined with liposomal doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abraxane combined with liposomal doxorubicinDrug
Patients with advanced or unresectable angiogenic sarcoma who met the criteria of treatment failure received abraxane combined with liposomal doxorubicin regimen. Administration regimen: abraxane 220 mg / m2 D1 plus liposomal doxorubicin 35 mg / m2 D1, IV drip, 3 weeks as a cycle, until the disease progression or intolerable toxicity. Up to 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Abraxane combined with liposomal doxorubicin | Experimental | Abraxane combined with liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma Receives: Drug: Abraxane combined with liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate (ORR) of patients with advanced or unresectable angiosarcoma treated with abraxane combined with liposomal doxorubicin
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start21 May 2021
- Primary completion20 May 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angiosarcoma MetastaticStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
- Investigators
- Xing Zhang, Principal investigator, Sun Yat-sen University CancerCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859465
- Sponsor's protocol ID
- Angiosarcoma
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma--an Open, Single Arm, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT04859465
- Acronym / sponsor ID
- Angiosarcoma
- Conditions
- Angiosarcoma Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 26 Apr 2021 (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 purpose is to explore the efficacy and safety of the combination of albumin-bound paclitaxel and liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma.
Detailed description
Soft tissue sarcoma (STS) is a relatively rare malignant tumor. In recent years, the disease has been increasing gradually. As an important biological feature of soft tissue sarcoma is local recurrence and distant metastasis, most patients die of distant metastasis. Despite the improvement of local control rate, more than 50% of patients died of unresectable or distant metastasis due to tumor progression. Doxorubicin and ifosfamide based chemotherapy is the standard first-line treatment for patients with relapsed / distant metastasis / unresectable advanced soft tissue sarcoma. For patients who fail or cannot tolerate first-line treatment, the choice of treatment is still limited. At present, some clinical patients who failed to receive standard treatment have tried to use the albumin-bound paclitaxel and liposomal doxorubicin regimen, with the ORR of 33% and PFS of about 8 months. As a new combination of chemotherapy drugs, more targeted phase II clinical studies are needed to evaluate the efficacy and safety of the new chemotherapy drugs in a variety of cancer species. In view of the above problems, this study aims to observe and explore the efficacy and safety of the combination of albumin-bound paclitaxel (keaili) and liposomal doxorubicin (duomeisu) in the treatment of advanced angiogenic sarcoma patients, and to provide better treatment options for patients with advanced sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane combined with liposomal doxorubicin | Experimental | Drug: Abraxane combined with liposomal doxorubicinAbraxane combined with liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patients voluntarily participated in the study and signed the informed consent; In all advanced angiogenic sarcomas confirmed by pathology, the standard treatment failed or there was no standard treatment or the standard treatment could not be tolerated. There is at least one measurable lesion according to RECIST 1.1, mainly including angiosarcoma, epithelioid hemangioendothelioma, epitheliosarcoma hemangioendothelioma, pseudomyogenic hemangioendothelioma, Kaposi sarcoma, malignant solitary fibroma / hemangiopericytoma, malignant glomus tumor, etc.
- Patients in advanced stage with unresectable lesions or lymph node or distant metastasis by imaging evaluation;
- In the past three months, there was at least one target lesion that could be measured according to RECIST version 1.1 standard, and it could be accurately measured in at least one direction (the maximum diameter needs to be recorded) by MRI or CT, including conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.
- 18-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;
- The main organ function met the following criteria within 7 days before treatment (1) Blood routine examination standard (without blood transfusion within 14 days)
Key exclusion criteria (24 listed)
- 1) Patients who have previously received abraxane treatment.
- 2) There were other malignant tumors in the past 5 years or at the same time, except for the cured cervical carcinoma in situ, skin cancer without melanoma and superficial bladder tumor (TA (non invasive tumor), tis (in situ cancer) and T1 (tumor infiltrating basement membrane);
- 3) Systemic anti-tumor treatment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C use within 6 weeks prior to the treatment of the trial drug), is planned within 4 weeks before the group is given or during the study medication. The radiotherapy was performed within 4 weeks before the group or the limited field radiotherapy was performed within 2 weeks before the group;
- 4) With pleural effusion or ascites, respiratory syndrome (≥ CTC AE class 2 dyspnea (dyspnea 2 refers to shortness of breath when a small amount of activity is used; It can affect instrumental daily life activities);
- 5) No remission of toxic reactions caused by any previous treatment was higher than that of CTC AE (4.01), excluding hair loss and lymphocyte reduction;
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 |
|---|---|---|
| Abraxane combined with liposomal doxorubicinPatients with advanced or unresectable angiogenic sarcoma who met the criteria of treatment failure received abraxane combined with liposomal doxorubicin regimen. Administration regimen: abraxane 220 mg / m2 D1 plus liposomal doxorubicin 35 mg / m2 D1, IV drip, 3 weeks as a cycle, until the disease progression or intolerable toxicity. Up to 8 cycles. | Drug | Abraxane combined with liposomal doxorubicin |
Primary outcome
Overall response rate (ORR)
Time frame: up to 24 months
Overall response rate (ORR) of patients with advanced or unresectable angiosarcoma treated with abraxane combined with liposomal doxorubicin
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 12 Jun 2026.
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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.
Xing Zhang principal investigator
Sun Yat-sen University CancerCenter
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 Abraxane combined with liposomal doxorubicin in people with Angiosarcoma Metastatic, 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 11 inclusion and 24 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 12 Jun 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 Xing Zhang (02087343383, zhangxing@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 24 months). 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 12 Jun 2026.