A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor

Inclusion Criteria

• •Must be confirmed as desmoid tumor by histopathology
• •Patients should have measurable lesions defined by RECIST v1.1
• •One of the following conditions is satisfied
• •1. The disease should be defined as non resectable or tumor with disability after resection. The definition standard should meet one or more of the following characteristics
• •* Multiple lesions
• •* The disease has involved or does not have enough blood vessel nerve bundle, bone, skin and fascia resection boundary
• •* Large tumor or multiple chambers involved
• •2. Imaging showed progress (increased by 10% according to RECIST v1.1 standard size within 6 months before enrollment)
• •3. The BPI score of patients with symptomatic diseases was more than 3 points and met one of the following conditions:
• •* NSAIDs can not control pain, and consider increasing the control of narcotic drugs
• •* Current use of narcotic drugs increased by 30%
• •* New opioid anesthetics needed
• •Patients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2
• •Age ≥ 1 year old, male or female
• •ECoG score ≤ 2
• •Results of laboratory examination during screening: blood routine test: white blood cell count ≥ 3.0x 109 / L, absolute value of neutrophil ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L, hemoglobin ≥ 90 g / L; liver function: total bilirubin Results: serum creatinine ≤ 1.5 times of the upper limit of normal value; patients without liver metastasis had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal value; patients with liver metastasis had ALT and AST ≤ 5 times of the upper limit of normal value; renal function: serum creatinine ≤ 1.5 times of the upper normal value or creatinine clearance rate ≥ 50 ml / min, and urine protein \< 2+
• •Female subjects of childbearing age, male subjects and partners of male subjects agreed to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, contraceptive injection or subcutaneous implantation) during the study and within 6 months after the infusion of study drug)
• •Understand and accept the requirements of the study, provide written informed consent and authorization for the use and disclosure of protected information, and agree to comply with the research requirements and return to conduct the required visits