chordoma
Conditions
Interventions
ONE:Camrelizumab:
PD-1 antibody SHR-1210: SHR-1210 is administered intravenously, with a fixed dose of 200 mg, for 30 minutes (the overall infusion time is not less than 20 minutes and not more than 6
Apatinib:
250 mg, taken orally every day, about half an hour after meals (the interval of taking medicine every day should be the same as possible), and taken with warm water.
Karelizumab combined wit
Sponsors
xuanwu hospital capital medical university
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. The age is ?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. Patients with advanced chordoma confirmed by histopathology; 5. There are lesions that can be evaluated by imaging. According to the evaluation standard of solid tumor curative effect (RECIST 1.1, see Annex 2), there is at least one single-diameter measurable lesion, and its longest diameter is measured by spiral CT = 10 mm;; 6. All acute toxic reactions caused by previous anti-tumor treatments were relieved to 0-1 level (according to NCI CTCAE version 5.03) 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; 7. 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 inspection shall meet the following standards: A. total bilirubin (TBIL) 45 ml/min. 8. 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; 9. 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: 1. Except the subjects whose toxicity has not recovered from previous anti-tumor treatments (concurrent chemoradiotherapy and surgical treatment) (alopecia, alkaline phosphatase, transglutaminase (GGT) or who can be enrolled after discussion with researchers and sponsors. 2. Immunosuppressive drugs have been used within 14 days before the first use of Karelizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones with physiological dose (that is, no more than 10 mg/ day of prednisolone or other corticosteroids with the same drug physiological dose); 3. Previously received the following therapies: anti-PD-1, anti-PD-L1, anti-VEGFR antibody or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (for example, CTLA-4, OX-40, CD137); 4. Uncontrollable hypertension (systolic blood pressure = 150 mmHg or diastolic blood pressure = 90 mmHg, despite systematic drug treatment); 5. 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; Note: On the premise that the international normalized ratio (INR) of prothrombin time INR)= 1.5, it is allowed to use low-dose heparin (the daily dosage for adults is 0.6 ~ 12,000 U) or low-dose aspirin (the daily dosage is = 100 mg) for preventive purposes; 10. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or unexplained fever > 38.5°C; occurred during the screening period/before the first administration; 11. 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; 12. Have received major surgery or severe traumatic injury, fracture or ulcer within 4 weeks before joining the group; 13. 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 hepatitis B and hepatitis C co-infection; 14. Patients with a clear allergic history may be potentially allergic or intolerant t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival ;Objective remission rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactChen Zan
xuanwu hospital capital medical university
Outcome results
None listed