Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unre… (NCT04859465) | Clinical Trial Compass
UnknownPhase 2
Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma
China69 participantsStarted 2021-05-21
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion 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 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)
✓. 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.
Exclusion criteria
✕. The patients with poor blood pressure control (systolic pressure ≥ 150 mmHg and diastolic pressure ≥ 100 mmHg) were found;