desmoid tumor
Conditions
Interventions
Vorolanib Group:Based on Simon two-stage optimal design, 5 patients are planned to be enrolled in the first stage and 13 patients are planned to be enrolled in the second stage. Vorolanib Tablets will
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of desmoid tumors; 2. Age >= 18 years and =1500/µL, platelets count >= 80,000/µL, and hemoglobin >=9.0 g/dL; 8. International normalized ratio = 60 mL/min using the Cockcroft-Gault formula (Ccr is calculated only when baseline Cr > 1.5×ULN); 10. ALT and AST = 50%; 12. 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; 13. Toxicity related to previous anti-tumor treatment must have recovered to <=grade 1 (CTCAE V5.0), but patients with any grade of alopecia are allowed to enter the study; 14. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Simultaneously suffering from other malignant tumors; 2. Previously received anti-angiogenic drug; 3. Active infections, such as HIV infection, Serum hepatitis B virus DNA>= 1×10^3 copies/mL or positive hepatitis C virus antibody, active tuberculosis, etc.; 4. Women in lactation or pregnancy; 5. History of major surgery or trauma within 28 days before the treatment of trial drug; 6. Suffering from severe cardiovascular and cerebrovascular diseases: myocardial infarction within 6 months, uncontrolled arrhythmia (including QTc interval >= 450 ms for men and >= 470 ms for women); heart failure of NYHA class III-IV, or left ventricular ejection fraction (LVEF) = 3 bleeding event; or unhealed wounds, fractures, active ulcers in the stomach and duodenum, ulcerative colitis, or other digestive tract diseases, or unremoved tumors with active bleeding, or other conditions that the researcher deems may cause gastrointestinal bleeding or perforation; 13. Other factors that the researcher deems unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Progression Free Survival;Median Overall Survival;Objective Response Rate;Disease Control Rate;Safety;Symptom improvement rate; | — |
Countries
China
Contacts
Public ContactYu Jiang
West China Hospital, Sichuan University
Outcome results
None listed