rhabdomyosarcoma in adult
Conditions
Interventions
Interventions group:Vincristine:
Dosage: 1.5 mg/m2
Administration: Intravenous infusion on Day 1 (D1)
Treatment cycle: Every 2 weeks
Irinotecan Liposome:
Dosage: 56.5 mg/m2
Administration: Intravenou
b) Patient mortality
c) Development of intolerable toxicity.
Sponsors
Beijing 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. Age >= 18 years old, regardless of sex; 2. The score of physical condition of the Eastern Cancer Cooperative Group (ECOG) is 0-1; 3. The expected survival time is >= 3 months; 4. Rhabdomyosarcoma by histopathology; 5. Recurrent or refractory rhabdomyosarcoma that has failed conventional treatment methods; 6. There are lesions that can be evaluated by imaging. According to the evaluation standard of solid tumor curative effect (RECIST 1.1), there is at least one unidimensionally measurable lesion, with a longest diameter of >= 10 mm measured by spiral CT; 7. All acute toxic reactions caused by previous anti-tumor treatments were relieved to 0-1 level (according to NCI CTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria (except for the toxicity such as alopecia that researchers think does not pose a safety risk to the subjects); If the subjects have undergone major surgery, they must have fully recovered from the complications before starting treatment; 8. The main organs function normally, that is, they meet the following standards: (1) The standard of routine blood examination should meet (blood transfusion and blood products have not been given within 14 days, and G-CSF and other hematopoietic stimulating factors have not been used for correction): a. hemoglobin (HB) >= 80 g/l; b. Neutrophil count (ANC) >= 1.5×109/L;/L; c. platelet count (PLT) >= 80×109/L;/l; (2) Biochemical examination shall meet the following standards: a. total bilirubin (TBIL) 45 ml/min. 9. Women of childbearing age must have taken reliable contraceptive measures or conducted a pregnancy test (serum or urine) within 7 days before entering the group, and the results are negative, and they are willing to adopt appropriate methods of contraception during the test period and 60 days after the last administration of the test drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and within 120 days after the last administration of the test drug; 10. The subjects volunteered to join the study and signed the informed consent form, which had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible for this study: 1.Known active central nervous system (CNS) metastasis and/or cancerous meningitis. Subjects who have previously received brain metastasis treatment can participate, as long as they remain stable and meet the following criteria: there is no evidence of imaging progress for at least four weeks before the first dose of experimental treatment, and any neurological symptoms have returned to baseline, there is no new or expanded evidence of brain metastasis, and steroids are not used for at least seven days before the experimental treatment. This exception does not include cancerous meningitis, regardless of its clinical stability; 2.Patients who have received prior irinotecan or apatinib; 3.Uncontrollable hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite systematic drug treatment); 4.Suffering from serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, and poorly controlled arrhythmia (including QTc interval >= 450 ms for men and >= 470 ms for women); ? ~ ? cardiac insufficiency (according to NYHA classification of new york Heart Association, see Annex 3), or left ventricular ejection fraction (LVEF) indicated by color Doppler echocardiography 1.5 ULN or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 6.Note: On the premise that the international normalized ratio (INR) of prothrombin time INR) 38.5°C occurred during the screening period/before the first administration; 8.Serious arterial/venous thrombosis events occurred within 12 months before joining the group, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism; 9.Have received major surgery or severe traumatic injury, fracture or ulcer within 4 weeks before joining the group; 10.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active pulmonary tuberculosis, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method) or co-infected with hepatitis B and hepatitis C; 11. Patients with a clear allergic history may be potentially allergic or intolerant to the biological agents of the research drugs; 12. There are obvious factors that affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of hollow organs occurred within 6 months; 13. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 14. Increase the risk associated with participating in the study or studying drugs, and according to the researcher's judgment, it may lead to other situations in which patients are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of overall Response;Overall Survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactTian Gao
Beiing Cancer Hospital
Outcome results
None listed