recurrent or refractory rhabdomyosarcoma
Conditions
Interventions
experimental group:pazopanib combined with TGI/CIV(nab-Paclitaxel+ gemcitabine + isocyclophosphamide/ cyclophosphamide +Irinotecan + vinorelbine)
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Histological or cytological diagnosis of rhabdomyosarcoma (RMS). 2. Patients who met the clinical diagnostic criteria and were diagnosed as having relapsed/refractory rhabdomyosarcoma. 3. The patient must have measurable lesions as recorded by the RECIST 1.1 standard. 4. Age >= 2 years old, 12 years) or Lansky score 70-100% (= 12 weeks. 7. Prior to initiating any project-related procedures, parents/guardians of child or adolescent subjects can Understanding, agreeing to, and signing research informed consent (ICF) and applicable child consent forms; Subject can Express consent with parental/guardian consent (if applicable). 8. Adequate organ and bone marrow function;
Exclusion criteria
Exclusion criteria: 1. The following treatments were received within 2 weeks before treatment: radiotherapy, chemotherapy, molecular targeted therapy for tumor; Other investigational drugs; Get a live attenuated vaccine. 2. Received anti-angiogenic targeted drugs within the past 3 months; 3. Central nervous system metastasis. 4. There was a history of thrombosis within 3 months before enrollment and the duration of anticoagulation treatment was less than 6 weeks. 5. Known bleeding tendency, clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to treatment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, vasculitis, etc.; Or arteriovenous thrombosis events occurring within 6 months prior to treatment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin is required, or long-term antiplatelet therapy (aspirin >=300 mg/ day or clopidogrel >=75 mg/ day) is required. 6. Recently, hypertension and proteinuria have not been controlled. And can not be well controlled by antihypertensive drug treatment; 7. Use antiepileptic drugs. 8. Long-term unhealed wounds, ulcers or fractures, major operations within 28 days before enrollment or minor operations within 7 days before enrollment, abdominal fistula, and gastrointestinal perforation. 9. Combined with uncontrolled severe infection; 10. Active heart disease in the 6 months prior to treatment, including myocardial infarction and severe/unstable angina pectoris. Left ventricular ejection fraction 450 ms in men and >470 ms in women).. 11. Have been diagnosed with any other malignancy within 3 years prior to treatment. 12. Known allergy to the investigational drug or any of its excipients. 13. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive with HBV DNA >= 500 IU/ml), hepatitis C (hepatitis C antibody positive with HCV-RNA above the lower detection limit of analytical methods). 14. According to the researchers' judgment, patients with large tumors, easy rupture and bleeding, and bleeding caused by tumor retreat are at greater risk. 15. In the investigator's judgment, there is a concomitant medical condition (such as poorly controlled high blood pressure, severe diabetes, neurological or psychiatric illness) or any other condition that seriously endangers the subjects' safety, may confuse the study results, or may interfere with the subjects' completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate,DCR;Quality of life score,QoL;Adverse Event,AE and Serious Adverse Event,SAE;Abnormal laboratory test indicators; | — |
Countries
China
Contacts
Public ContactWang Jingfu
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed