Soft-Tissue Sarcoma
Conditions
Interventions
Intervention group :Anlotinib plus investigator-selected chemotherapy
Control group:Investigator-selected chemotherapy alone
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable locally advanced or metastatic soft tissue sarcoma; 2. Age >=18 years; 3. Patients have progressed on both anthracycline-based chemotherapy and anlotinib treatment; 4. Having at least one measurable lesion according to RECIST 1.1; 5. An ECOG performance status score of 0-1; 6. Neutrophil count >= 1500/µL, platelets count >= 80000/µL, and hemoglobin >=9.0 g/dl; 7. International normalized ratio = 55%; 11. Women of reproductive age must have negative HCG test results in serum or urine within 7 days before enrollment, and are willing to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug, or those have been surgically sterilized or menopausal. For men, they must agree to use appropriate methods of contraception during the trial period and within 3 months after the last administration of the trial drug, or those have been surgically sterilized; 12. Other toxicity related to previous anti-tumor treatment must be restored to <= grade 1 (CTCAE V5.0), but patients with hair loss of any grade are allowed to enter the study; 13. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Having other malignant tumors at the same time; 2. Having symptomatic brain metastasis; 3. Patients who could not tolerate the 8mg dose level of anlotinib on previous treatment; 4. Patients with disease progression as the first efficacy evaluation of previous treatment with anlotinib; 5. Having active infection, such as HIV infection, hepatitis B virus DNA quantitation >= 1 × 10^3 copies/ml or hepatitis C virus antibody positive, active tuberculosis, etc; 6. Lactating or pregnant women; 7. The pathological subtypes were gastrointestinal stromal tumor, embryonal or alveolar rhabdomyosarcoma, classical dermatofibrosarcoma protuberans, Ewing's sarcoma/primitive neuroectodermal tumour, small round cell sarcoma with EWSR1-non-ETS fusion, CIC-rearranged sarcoma, sarcoma with BCOR genetic changes, clear cell sarcoma, alveolar soft tissue sarcoma, malignant mesothelioma, etc; 8. Having a history of major surgery or trauma within 28 days before the treatment of trial drug; 9. Severe cardiovascular and cerebrovascular diseases including grade >= 2 myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >= 450 ms for men and >= 470 ms for women); according to NYHA standard, grade III ~ IV cardiac dysfunction, or left ventricular ejection fraction (LVEF) = grade 3 bleeding event, unhealed wound, fracture, active ulcer of stomach and duodenum, ulcerative colitis, or other conditions that might cause gastrointestinal bleeding and perforation determined by the researcher; 15. Other factors that researchers consider inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Overall Survival;Objective Response Rate;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactYu Jiang
West China Hospital, Sichuan University
Outcome results
None listed