inflammatory myofibroblastoma (IMFT)
Conditions
Interventions
Group 1:Crizotinib plus camrelizumab
Group 2:Apatinib plus camrelizumab
Sponsors
Peking University Cancer Hospital and Institute
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 14 years, male or female; 2. Locally advanced or metastatic inflammatory myofibroblastoma confirmed by histopathology, which cannot be surgically and radically removed; 3. Have not received any immunotherapy or targeted therapy for IMFT (molecular targeted therapy, including immunotherapy with CTLA-4, PD-1/PD-L1 monoclonal antibody) in the past; 4. ECOG score: 0-1; 5. Expected survival time >= 12 weeks; 6. At least one measurable lesion that meets the RECIST v1.1 standard (according to the RECIST v1.1 requirements, the long diameter of the measurable lesion on spiral CT scanning is >= 10mm or the short diameter of the enlarged lymph node is >= 15mm; 7. Sufficient bone marrow reserves and organ functions: 1) The blood routine examination should meet the following requirements (no blood transfusion and blood products within 14 days, and no G-CSF and other hematopoietic stimulators were used for correction): a. Hemoglobin (Hb) >= 90 g/L; b. Number of neutrophils (ANC) >= 1.5 × 10^9/L c. Platelet count (PLT) >= 75 × 10^9/L 2) Biochemical examination shall meet the following standards: a. Total bilirubin (TBIL) 60ml/min (Cockcroft Gault formula); d. Routine urine test results showed that urinary protein (UPRO) < 2+or 24-hour urine protein quantification < 1g; 8. Women should agree to use contraceptives (such as IUD, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine pregnancy test was negative within 7 days before the study was included, and the patient must be a non lactating patient; Men should agree with patients who must use contraception during the study period and within 6 months after the end of the study period; 9. Subjects are willing to, understand and sign the informed consent form, and can abide by the agreement.
Exclusion criteria
Exclusion criteria: 1.Have suffered from malignant tumors other than IMFT within 5 years; However,the cured localized tumors are excluded, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ. 2. Uncontrolled pericardial effusion, uncontrollable pleural effusion or clinically significant moderate ascites during screening are defined as meeting the following criteria: during screening, pleural and peritoneal effusion can be detected with clinical symptoms and physical examination; Or in the screening process, pleural and peritoneal effusion needs to be treated by puncture and/or intracavitary drug delivery. 3. Original history of serious heart and cerebrovascular diseases: (1) Congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident stroke or poorly controlled arrhythmia of NYHA Grade II or above within 12 months before enrollment; (2) LVEF (left ventricular ejection fraction) 480ms (calculated by Fridericia method, if QTc is abnormal, it can be detected 3 times continuously every 2 minutes, and the average value is taken). Patients with congenital long QT syndrome should avoid taking Cozotinib capsule; (4) Hypertension that is difficult to control by drugs (systolic blood pressure (BP) >= 150 mmHg and/or diastolic blood pressure >= 100 mmHg) (based on the average value of >= 3 BP readings obtained from >= 2 measurements); (5) Hypertensive crisis or hypertensive encephalopathy has occurred in the past. 4. There are other evidence of obvious bleeding tendency or major coagulation disorder: (1) Clinically significant hemoptysis or tumor bleeding of any cause within 2 weeks before enrollment; (2) Thrombosis or embolism occurred within 6 days before enrollment; (3) Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin therapy) was used within 2 weeks before enrollment; (4) Antiplatelet therapy is required. 5. During the study period, when strong inhibitors of CYP3A4 (itraconazole, clarithromycin, voriconazole, telithromycin, saquinavir, ritonavir, etc.) are used at the same time, local use of these drugs can be allowed, such as 2% ketoconazole ointment. Within 12 days before the first use, inducers of CYP3A4, including but not limited to dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, rifapentine, etc., cannot be used at the same time; 6. He received medium and large surgical treatment within 4 weeks before enrollment, but diagnostic biopsy was not included. 7. Central nervous system metastasis; If suspected, brain and/or spinal cord MRI scanning is required to exclude. 8. Suffer from severe unhealed wound, active ulcer and untreated fracture. 9. Inoculate live vaccine within 30 days before enrollment. 10. The patient has immune deficiency or is receiving long-term systemic steroid treatment (daily dose of prednisone exceeds 10mg or other glucocorticoids with equivalent efficacy) or other immunosuppressive drugs within 7 days before enrollment. 11. In the past 2 years, patients with active autoimmune diseases requiring systemic treatment (i.e. immunomodulatory drugs, corticosteroids or immunosuppressive drugs); However, replacement therapy (such as thyroxine, insulin or physiological corticosteroid replacement therapy due to adrenal or pituitary insufficiency) will not be considered as systemic therapy and can be used. 12. Have a clear history of interst
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response,DoR;Disease Control Rate,DCR;Progression-free survival,PFS;Overall survival,OS;Rate of adverse events; | — |
Countries
China
Contacts
Public ContactWang Zhen
Peking University Cancer Hospital and Institute
Outcome results
None listed