A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma
This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.
• Age≥18 years and≤70 years;
• According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.
• No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.
• At least one measurable and assessable lesion defined by RECIST 1.1;
• ECOG performance status of 0-1;
• Estimated life expectancy≥6 months;
• Pulmonary function is basically normal;
• Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g/L; b) Leukocyte≥3.5x10\^9/L; c) The absolute neutrophil count (ANC)\>1.5x10\^9/L; d) Platelet≥100x10\^9/L; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \[mainly unconjugated bilirubin\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g/L; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);
• Obtain the written informed consent of the patient/legal representative;
⁃ Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.