Classic osteosarcoma
Conditions
Interventions
single arm:Anlotinib combined with Doxorubicin and cisplatin
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
15 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age between 15 to 40 years, male or female; BSA should be above 1.2m2 if patients are younger than 18 years; 2. Patients with histologically diagnosed primary localized extremity classic osteosarcoma (High-grade intramedullary osteosarcoma); 3. Enneking stage IIB; 4. Measurable disease by RECIST 1.1; 5. ECOG status score is 0-1; Expected survival time is >= 6 months; 6. No previous anti-tumor treatments; 7. Normal organ function is required as below: (1) Hemoglobin >=90g/L; (2) Absolute neutrophil count >=1.5x10^9/L; (3) Platelet count >=80x10^9/L; (4) Total bilirubin 40mL / min (using the standard Crockcroft-Gault formula); (7) Echocardiography to detect LVEF >= 50%. 8. Women are not pregnant, having negative serum HCG test within 7 days before study enrollment. All patients without surgical sterilization need to take effective contraception during the study period and within 3 months after the end of the study treatment period; 9.Ability to understand and be willing to sign the informed consent form of this trial.
Exclusion criteria
Exclusion criteria: 1. The patient is participating in other clinical studies or is less than 4 weeks from the end of the previous clinical study; 2. Patients who have had or are currently suffering from other active malignant tumors within 5 years, except those who have undergone possible curative treatment and have no relapse of skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical cancer in situ within 5 years after the treatment; 3. Patients with uncontrollable hypertension (despite the best drug treatment, there are still systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg,); 4. Patients with unresponsive toxic reactions higher than CTCAE level 1 due to any previous treatment, excluding hair loss; 5. Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5) ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment; note: on the premise that the international standard ratio of prothrombin time (INR) is less than or equal to 1.5, it is allowed to use low-dose heparin (6000-12000 U / day for adults) or aspirin (100 mg / day) for prevention purposes; 6. Patients with renal insufficiency: urine routine indicates urine protein >= + +, or confirmed 24-hour urine protein >= 1.0g; 7. Patients who had undergone surgery within 28 days before admission; 8. According to nci-ctcae 4.03, patients with pleural effusion or pneumothorax of grade 3 or above; 9. Severe acute or chronic infection requiring systemic treatment; 10. Patients with severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poor control of arrhythmia (including QTc interval >= 450 ms for men and 470 MS for women); according to NYHA standard, grade III-IV cardiac insufficiency, or color Doppler examination of the heart indicating left ventricular ejection fraction (LVEF) 10mmol / L); 13. Patients with significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 14. Patients with significant clinical bleeding symptoms or definite bleeding tendency in the first 3 months, such as respiratory tract bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood + + or above at baseline, or with vasculitis, etc; 15. Patients with untreated active hepatitis (hepatitis B: HBsAg positive and HBV DNA >= 500iu / ml; hepatitis C: HCV RNA positive and abnormal liver function); CO infection with hepatitis B and C; 16. The patients who had the event of arteriovenous thrombosis in the first 6 months, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc; 17. Patients with tumor thrombus; 18. Patients who have a history of psychoactive drug abuse and are unable to quit or suffer from uncontrollable neurological, mental illness or mental disorder, have poor compliance and are unable to cooperate with and describe the treatment response; 19. According to the judgment of the investigator, the patient may have other factors that may lead to the forced termination of the study, such as other serious diseases or severe laboratory examination abnormalities or other factors that may affect the safety of the subject, or the family or society of the test data collect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-month Event-Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 36-month Event-Free Survival Rate;local recurrence rate;lung metastasis rate;3-year Overall Survival Rate;safety; | — |
Countries
China
Contacts
Public ContactChongqi Tu
West China Hospital of Sichuan University
Outcome results
None listed