Soft Tissue Sarcoma
Conditions
Interventions
Group 1:Surufatinib+Gemcitabine
Group 2:Surufatinib
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this research and sign the informed consent voluntarily; 2. Multiple histologically confirmed subtypes of soft tissue sarcoma, including: (1) Patients enrolled in cohort 1 included: diagnosed with soft tissue sarcoma, excluding well-differentiated liposarcoma, gastrointestinal stromal tumor, ALK+ inflammatory myofibroblastic tumor, primary bone tumor, non-pleomorphic rhabdomyosarcoma, Ewing Sarcoma, Acinar Soft Tissue Sarcoma, Clear Cell Sarcoma, Kaposi's Sarcoma; (2) The patients enrolled in cohort 2 included: diagnosed with soft tissue sarcoma, excluding well-differentiated liposarcoma, myxoid liposarcoma, gastrointestinal stromal tumor, ALK+ inflammatory myofibroblastic tumor; 3. Cohort 1: Patients who failed first-line standard treatment chemotherapy (including anthracyclines) (progression or new lesions within half a year of perioperative chemotherapy, also defined as first-line standard treatment chemotherapy failure); Cohort 2: Anluo Patients who have failed treatment with anlotinib; treatment failure is defined as: disease progression during anlotinib treatment or within 6 months after the last treatment; or intolerable toxic side effects during treatment; Remarks: Upfront neoadjuvant or adjuvant chemotherapy is allowed. Neoadjuvant/adjuvant therapy was considered failure of first-line systemic chemotherapy for progressive disease if disease progression/relapse occurred during neoadjuvant/adjuvant therapy or within 6 months after the end of therapy; 4. Aged 18 to 75 years; 5. The patient must have at least one measurable lesion (RECIST 1.1); 6. ECOG PS score: 0-1 points; 7. Expected survival period >= 3 months; 8. The main organs function normally; 9. Females of childbearing age should agree to use contraceptive measures (such as intrauterine device [IUD], contraceptives or condoms) during the study period and within 6 months after the end of the study; Serum pregnancy test within 7 days before study enrollment Negative, and must be non-lactating subjects; males should be subjects who agree to use contraception during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Patients who have received surufatinib treatment in the past; 2. Received previous anti-tumor treatment within 21 days before enrollment or received any experimental drug treatment within 21 days before enrollment. 3. Received major surgery, open biopsy or major trauma within 4 weeks before enrollment; 4. The patient currently has hypertension that cannot be controlled by drugs, defined as: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 5. The urine routine indicates that the urine protein is >= 2+, and the 24-hour urine protein quantification is >1.0g. 6. Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [known as hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e. HBV DNA Positive (greater than the lower limit of normal detection; > 1 x 10^4 copies/mL or > 2000 IU/mL); known hepatitis C virus infection (HCV) and HCV RNA positive (>1 x 10^3 copies/mL), or other hepatitis , liver cirrhosis] (excluding patients whose relevant test results returned to normal after antiviral treatment in the early stage); 7. The patient currently has central nervous system (CNS) metastasis or has brain metastasis in the past; 8. Women who are pregnant (positive pregnancy test before taking the drug) or are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Objective response rate (ORR);Overall survival time(OS);Quality of life score (QoL);safety endpoint; | — |
Countries
China
Contacts
Public ContactZhou Yuhong
Zhongshan Hospital, Fudan University
Outcome results
None listed