PLD and IFO As First-line Treatment for Patients With Advanced or Metastatic STS

Pegylated-liposome Doxorubicin Combined With Ifosfamide As First-line Treatment for Patients With Advanced or Metastatic Soft Tissue Sarcoma

This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

Inclusion Criteria:

• aged 18-70 years with histologically confirmed advanced or metastatic STS
• Eastern Cooperative Oncology Group performance status of 0 to 2
• life expectancy of ≥ 3 months
• have not received chemotherapy before
• at least one measurable lesion
• LVEF≥50%
• have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

• osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma protuberans
• patients with symptomatic brain metastases
• active clinical severe infection