Desmoid-type fibromatosis
Conditions
Interventions
radiotherapy combined with Bevacizumab:Bevacizumab+radiotherapy
Sponsors
Sichuan Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent with well compliance and follow-up; 2. Age =18 years old, gender unlimited; 3. For patients with postoperative residual (R2 excision)/recurrent or inoperable desmoid-type fibromatosis who progressed after first-line close observation, the evaluation criteria for progress were required based on the v1.1 "Criteria for Evaluation of Efficacy in Solid Tumors", and the interval between two imaging examinations was within 6 months. 4. The primary tumor is measurable 5. Life expectancy is at least 3 months 6. ECOG score: 0-2; 7. If the major organs are functioning normally, the following criteria are met: (1) The standard of blood routine examination shall be met (no blood transfusion or blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors) : a. HB=90 g/L; b. ANC=1.5×109/L; c. PLT=80×109/L; (2) Biochemical examination shall meet the following standards: A. TBIL 45 ml/min (Cockcroft - Gault formula); 8. There is no contraindication for the use of bevacizumab, and bevacizumab treatment should not be started at least 28 days after major surgery, or should not be started until the wound is completely healed; 9. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug;
Exclusion criteria
Exclusion criteria: 1. Other pathological types of soft tissue tumors; 2. Residual patients with R1 excision after surgery. 3. Patients who have previously received antiangiogenic therapy. 4. History and complications 1) Patients are participating in other clinical studies or less than 4 weeks after the end of treatment of the previous clinical study; 2) Other active malignancies requiring concurrent treatment (excluding metastases); 3) Uncontrolled hypertension (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg despite optimal medical treatment); 4) A history of malignancy. The exception is for patients who have undergone potentially curable therapy and are free of disease recurrence for 5 years from the start of therapy; 5) Antitumor treatment-related adverse reactions (except hair loss) did not recover to NCI-CTCAE4.0=1 after previous chemotherapy and surgical resection; 6) Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the premise of INR = 1.5, low-dose heparin (adult daily dose: 0.6000-12,000 U) or low-dose aspirin (daily dose: 100 mg or less) is allowed for prophylactic purposes. 7) Renal insufficiency: urine routine indicated urine protein = ++, or confirmed 24 hours urine protein volume =1.0g; 8) For subjects with major surgery or severe trauma, the effects of surgery or trauma have been resolved less than 28 days before enrollment; 9) Severe acute or chronic infections requiring systemic treatment; 10) Severe cardiovascular disease: Grade ? or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =450 ms in men and 470 ms in women); According to NYHA criteria, patients with grade ? to ? cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by color Doppler examination; 11) Wounds or fractures that have not healed for a long time; 12) decompensated diabetes mellitus or other contraindications with high-dose glucocorticoid therapy; 13) Bleeding symptoms of significant clinical significance or definite bleeding tendency, such as respiratory tract bleeding, digestive tract bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis within 3 months before enrollment; 14) arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 12 months before enrollment; 3. According to the investigator's judgment, the patient may have other factors that may lead to the termination of the study, such as other serious diseases or serious abnormalities in laboratory tests or other family or social factors that may affect the safety of the subjects, or the collection of test data and samples;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the event-free Survival rate at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| the Events-Free Survival (EFS) rates at 24 months and 36 months;Overall survival (OS);Progression Free Survival (PFS);Objective Response Rate (ORR);Disease Control Rate (DCR);Safety;Quality of life (QoL); | — |
Countries
China
Contacts
Public ContactQifeng Wang
Sichuan Cancer Hospital & Institute
Outcome results
None listed