About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Abraxane combined with liposomal doxorubicin
DrugPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Overall response rate (ORR)
Overall response rate (ORR) of patients with advanced or unresectable angiosarcoma treated with abraxane combined with liposomal doxorubicin
Sponsors and contacts
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