desmoid tumor
Conditions
Interventions
Interventions group:Famitinib malate capsule: 20 mg, oral once a day, about half an hour after meal (the daily medication should be the same as possible), take with lukewarm water
continuous medication, 3 weeks as a cycle.
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following selection criteria to be enrolled in this trial: 1. Hard fibroma confirmed by pathology. 2. There are measurable lesions in accordance with the RECIST1.1 standard. 3. Male or female, >= 18 years old, & lt;70 years old. 4. The physical condition of ECOG is 0-2. 5. In the past 6 months, there has been imaging evidence of recurrence or disease progression (according to RECIST criteria). 6. Imaging evaluation meets the inoperable criteria as follows: (1) radical surgery can cause large defects of skin, muscles and other soft tissues, resulting in huge changes in the appearance and loss of function of the limbs, or major reconstruction operations such as patch repair and skin flap repair; (2) radical surgery is bound to involve major blood vessels and nerves; (3) the tumor is involved in the bone and the safe cutting edge cannot be reached on the premise of preserving the bone. (4) by explaining the patient's condition, the patient refused to try the operation after weighing the pros and cons; (5) amputation was not considered. 7. The function of the main organs is normal, that is, the following criteria are met: hemoglobin (Hb) >= 95g/L Neutrophils (ANC) >= 1.5 × 10^9 Gy / L, platelet count (PLT) >=80 × 10^9 / L, serum creatinine (Cr) = 35g/L prothrombin time (PT) and partial prothrombin time (PTT) =50%; 8. The patient informed consent and signed a written consent form. 9. The patient has good compliance and voluntarily accepts follow-up, treatment, laboratory examination and other research steps as planned.
Exclusion criteria
Exclusion criteria: 1. Previously received tyrosine kinase inhibitor (TKI) drugs (such as amlotinib, pezopanil, sorafenib, etc.) for treatment; 2. Respiratory syndrome caused by pleural effusion or ascites (>= CTC AE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath during a small amount of activity; affects instrumental activities of daily life]) 3. Other malignant tumors have occurred or are currently suffering from other malignant tumors within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (primary carcinoma) and T1 (tumor infiltrating basement membrane). 4.Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before receiving experimental drug therapy), was planned within 4 weeks before entering the group or during the period of medication in this study. Expanded field radiotherapy (EF-RT) was performed within 4 weeks before enrollment, or field-limited radiotherapy was performed within 2 weeks before grouping. 5.Unalleviated toxicity higher than CTC AE (4. 0) 1 due to any previous treatment, excluding alopecia. 6.Patients with multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.) 7.Patients with any severe and / or uncontrolled diseases, including: (1) patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); (2) patients with a significant history of cardiovascular disease, including, but not limited to: (1) congestive heart failure (NYHA grade > 2); (2) unstable angina pectoris; (3) myocardial infarction in the past 6 months; (4) any supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention. (3) active or uncontrolled severe infection (>=CTCAE grade 2 infection) that requires antibiotics, antiviral or antifungal control; (4) liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment;(5) Renal failure requires hemodialysis or peritoneal dialysis; (6) patients with a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; (7) poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L); (8) urinary protein >= + + indicated by urine routine and confirmed that 24-hour urinary protein was more than 1.0g. (9) patients with seizures requiring treatment; (10) patients with hypothyroidism: TSH>4.2mlU/L; (11) subjects with any disease that may increase the risk of gastrointestinal bleeding or perforation: such as active ulcer of the dissolving tract, known intraluminal metastases, inflammatory bowel disease, history of abdominal fistula, gastrointestinal perforation or abdominal abscess within 28 days before the start of the study. (12) known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) 8. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping; 9. Imaging showed that the tumor had invaded the important blood vessels or was judged by the researchers to be very likely to invade the important blood vessels and cause fatal bleeding during the follow-up study; 10. Patients with any physical signs or history of bleeding, r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate;12-month progression-free survival rate;Progression-free survival ;Disease control rate;,security; | — |
Countries
China
Contacts
Public ContactZhengfu Fan
Peking University Cancer Hospital
Outcome results
None listed