Soft Tissue Sarcoma
Conditions
Keywords
soft tissue sarcoma, Fruquintinib
Brief summary
To evaluate the efficacy of Fruquintinib in patients with chemotherapy insensitive or chemotherapy resistant soft tissue sarcoma
Detailed description
This trial is an open, single arm, single center, prospective phase II clinical study. Objective:To observe the efficacy and safety of Fruquintinib in the first-line treatment of desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma or second-line and posterior line treatment of angiosarcoma.
Interventions
DRUGFruquintinib
To observe the efficacy and safety of Fruquintinib in the first-line treatment of desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma or second-line and posterior line treatment of angiosarcoma.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Only those who meet all of the following criteria can be selected: 1. Fully understand this study and voluntarily sign the informed consent form; 2. Male or female subjects / patients aged ≥ 18 years; 3. Non operative desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma and angiosarcoma with failed chemotherapy confirmed by histopathology; 4. Patients with desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma or angiosarcoma who failed to receive anti angiogenesis drugs in the past. 5. At least one measurable lesion meeting the requirements of RECIST version 1.1; If the focus that has previously received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only focus, there must be a clear imaging basis for the disease progression of the focus; 6. The ECoG score was 0 or 1; 7. The laboratory test results within 7 days before the first acceptance of the study drug must meet the following criteria: 1\) Neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 90 g / L (no blood transfusion, no blood products, no granulocyte colony stimulating factor or other hematopoietic stimulating factors within 7 days before laboratory examination); 2\) Total serum bilirubin ≤ 1.5 × Upper normal value (ULN); 3\) In the absence of liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN； ALT and AST ≤ 3 in patients with liver metastasis or liver cancer × ULN；［ Asymptomatic mild and moderate liver injury (defined as NCI CTCAE grade 1 toxicity) and elevated ALT and AST \> 5 \ 20 × Patients with ULN (NCI CTCAE Level 3) may tolerate the same dose of study drugs as patients with normal liver function. Patients with mild to moderate liver injury can be included on the premise that non clinical and clinical data (including pharmacokinetic and pharmacokinetic results) suggest that there is no unreasonable risk. If it is necessary to include patients with severe liver injury, it is necessary to discuss with the regulatory authority\] 4\) Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 ml / min (calculated according to Cockcroft Gault formula); 5\) Urine routine examination showed that urinary protein was \< 2 +; If urinary protein ≥ 2 +, 24-hour urinary protein quantification should be \< 1 g; 6\) International normalized ratio (INR) ≤ 1.5 and partially activated prothrombin time (APTT) ≤ 1.5 × ULN。 8\. Expected survival ≥ 12 weeks; 9\. Agree to abide by the regulations on smoking, drinking, diet and exercise restrictions during the study (which may cause more protocol violations, which shall be set according to the needs of the study); 10\. Female subjects / patients of childbearing age or male subjects / patients whose partners are women of childbearing age shall take effective contraceptive measures, such as double barrier contraceptive methods, condoms, intrauterine devices, abstinence, etc., from at least 1 month before receiving the study drug for the first time to 6 months after receiving the study drug for the last time.
Exclusion criteria
Those who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 months | progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 6 months | over survival |
| DCR | 2 months | disease control rate |
| ORR | 2 months | objective response rat |
| TTR | 2 months | time to response |
| AE | 2 months | Adverse Events |
| DoR | 2 months | duration of response |
Countries
China
Contacts
Primary ContactXiaowei Zhang, Doctor
Backup ContactWenxia Peng, Bachelor
Outcome results
None listed