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New treatment option for Angiosarcoma Metastatic
Official title Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma
ClinicalTrials.gov ID: NCT04859465
What this study is testing
What is Abraxane combined with liposomal doxorubicin?
Abraxane combined with liposomal doxorubicin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for angiosarcoma metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- The patients voluntarily participated in the study and signed the informed consent; In all advanced angiogenic sarcomas confirmed by pathology, the...
- 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...
- 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...
You likely can't join if
- 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 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;
See the full eligibility criteria
- 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...
- 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...
- 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; ③ Platelet count (PLT) ≥ 80 × 109 / L. (2) 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.