| Eligibility |
Inclusion Criteria:
1. The patients volunteered to participate in this study and signed the informed consent;
2. Pathologically confirmed advanced soft tissue sarcomas with at least one measurable
lesionMainly including Synovial sarcoma (Synovial sarcoma), Leiomyosarcoma
(Leiomyosarcoma), gland Alveolar soft tissue sarcoma (Alveolar soft part sarcoma),
Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (Undifferentiated
pleomorphic sarcoma/malignant fibrous histiocytoma), liposarcoma (AdipocyticEpithelial
sarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, and other
Tumors.Except for:Malignant peripheral nerve sheath tumor, Undifferentiated sarcoma,
Rhabdomyosarcoma, chondrosarcoma, Osteosarcoma, dermato-fibrosarcomaProtuberans,
gastrointestinal stromal tumor, Primitive neuroectodermal tumor, Inflammatory
myofibroblastic tumor, Malignant mesothelioma.
3. Patients who have failed treatment with at least one or two line chemotherapy regimen
(doxorubicin + ifosfamide, gemcitabine + docetaxel) within the last 6 months (except
for acinar soft tissue sarcoma);[note: treatment failure refers to the occurrence of
disease progression or intolerance during treatment or within 3 months of the last
treatment]
4. 18 ~ 70 years old;ECOG PS score is 0~1;Expected survival beyond 3 months;
5. Patients who are effective with other targeted drugs, but have drug resistance and
disease progression, and stop taking drugs for more than 4 weeks;
6. Major organ functions meet the following criteria within 7 days before treatment:
1. blood routine examination standard (in the condition of no blood transfusion
within 14 days) :
- hemoglobin (HB) =90g/L;
- absolute value of neutrophils (ANC)=1.5×109/L;
- platelet (PLT) =80×109/L
2. biochemical examination shall meet the following standards:
- total bilirubin (TBIL) =1.5 times the upper limit of normal value (ULN);
- alanine aminotransferase (ALT) and aspartate aminotransferase AST= 2.5×ULN,
if accompanied by liver metastasis, ALT and AST=5×ULN;
- serum creatinine (Cr)=1.5×ULN or creatinine clearance rate CCr=60ml/min;
3. doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = normal
low limit (50%).
7. Women of childbearing age should agree that they must obtain a certain amount during
the study period and within 6 months after the study Use contraceptives (such as
intrauterine devices, birth control pills or condoms);Negative serum or urine
pregnancy test within 7 days before study enrollment and must be non-lactating;Men
should agree to patients who must use contraception during the study period and within
6 months of the end of the study period.
Exclusion Criteria:
1. Patients who have previously used anlotinib hydrochloride capsules;
2. With pleural effusion or ascites, cause respiratory syndrome (=CTC AE grade 2
dyspnea);
3. Patients who have received targeted therapy of vascular endothelial growth inhibitors,
such as sunitinib, sorafenib, imatinib, bevacizumab, famitinib, apatinib, reagfenib
and other drugs, have failed to respond to treatment.Other malignancies were present
or present at the same time within 4.5 years, except cured carcinoma in situ of the
cervix, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive
tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
4. Systemic antitumor therapy, including cytotoxic therapy, immunotherapy, or mitomycin
C, was planned for the first 4 weeks of the group or in this study.Radiotherapy was
performed in the first 4 weeks or in the second 2 weeks before the grouping.
5. Unrelieved toxic reactions above CTC AE(4.0) level 1 due to any previous treatment,
excluding hair loss;
6. Having multiple factors affecting oral medications (such as inability to swallow,
chronic diarrhea and intestinal obstruction);
7. Patients with brain metastasis with symptoms or symptom control time less than 2
months;
8. Patients with any serious and/or uncontrolled illness, including:
1. Patients with unsatisfactory blood pressure control (systolic blood pressure =
150 mmHg, diastolic blood pressure = 100 mmHg);
2. Patients with grade I or above myocardial ischemia or myocardial infarction,
arrhythmia (including QTc=480ms) and grade ii or above congestive heart failure
(New York heart association grade (NYHA));
3. Active or uncontrolled severe infection (= grade CTC AE 2 infection);
- Patients with cirrhosis, decompensated liver disease, active hepatitis or
chronic hepatitis should receive antiviral treatment;
- Renal failure requires hemodialysis or peritoneal dialysis;
9. Patients with any serious and/or uncontrolled illness, including:
1. a history of immunodeficiency, including HIV positive or other acquired or
congenital immunodeficiency diseases, or a history of organ transplantation;
2. poor diabetes control (FBG > 10mmol/L);
3. the urine routine indicated that urine protein =++, and confirmed the 24-hour
urine protein quantitative > 1.0g.
4. patients with seizures requiring treatment;
10. Significant surgical treatment, open biopsy or significant traumatic injury received
within 28 days prior to grouping;
11. Any physical signs or history of bleeding, regardless of severity;Unhealed wounds,
ulcers or fractures were found in patients with any bleeding or bleeding event =CTCAE
level 3 within 4 weeks before grouping;
12. 6 months in the event of overactive/venous thrombosis, such as cerebrovascular
accident (including temporary ischemic attack), deep venous thrombosis and pulmonary
embolism;
13. Having a history of abuse of psychotropic substances and being unable to quit or
having mental disorders;
14. Participated in clinical trials of other anti-tumor drugs within four weeks; According
to the researchers' judgment, there are concomitant diseases that seriously endanger
patients' safety or prevent patients from completing the study.
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