Soft tissue sarcoma
Conditions
Interventions
single arm:albumin-bound paclitaxel plus gemcitabine
Sponsors
Department of Orthopedics, the Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects with the age from 16 years to 70 years; 2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;the ECOG performance status of 2 can be accepted after the amputation; 3) Life expectancy of at least 3 months; 4) Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy; 5) The histopathologic types (confirmed pathologically as epithelioid sarcoma, angiosarcoma, fibrosarcoma, rhabdomyosarcoma and undifferentiated pleomorphic sarcoma) Without prior systemic chemotherapy or relapse more than 6 months after the completion of last systemic chemotherapy; 6) Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 7) Acceptable liver function, renal function, hematologic status and coagulation function as specified in the protocol; 8) Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug; 9) Willingness to comply with the study protocol for any reason.
Exclusion criteria
Exclusion criteria: 1) Receiving any previous anticancer treatment, other investigational drugs or any attenuated live vaccine with 4 weeks of the first does of study drug; 2) Prior treatment with PD-1/PD-L1/CTLA-4 targeted drugs or VEGFR targeted drugs; 3) Plan to receive surgery or radiotherapy to treat the sarcoma during the trail; 4) Radiological evidence of brain metastases or primary tumors; 5) Diagnosed other malignancies within the last 3 years from the first dose of drug; 6) Known allergy to any of the treatment components; 7) Active infection including human immunodeficiency virus (HIV) ,HBV or HCV; 8) Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic response; | — |
Countries
China
Contacts
Public ContactJiaqiang Wang
Department of Orthopedics, the Affiliated Cancer Hospital of Zhengzhou University
Outcome results
None listed