An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases
Anticipated 30 subjects will be enrolled to receive Endostar, Gemcitabine and Docetaxel.
Endostar at a dosage of 7.5 mg/m2 will be administered on Day 1-14 of each cycle.
Gemcitabine (1000 mg/m2) will be administered on Day 1 and Day 8 of each cycle. Docetaxel
(75 mg/m2) will be administered on Day 2 of each cycle. An individual cycle of therapy will
be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple
cycles may be administered until the subject is PD or until a maximum of 6 cycles.
Time-to-progression (TTP) will be assessed using the Kaplan Meier method. Overall response
rate (ORR) as well as individual categories of response (CR, PR, SD, and PD) will be
determined using RECIST (v1.1). Evaluation of 1- and 2-year overall survival will also be
performed. Safety measures will be recorded using the NCI-CTCAE (v4.0).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression is defined as time from first study treatment dose to the progression disease.
Approximately 2 years
Peng Yuan, MD
Chinese Academy of Medical Sciences
China: Food and Drug Administration