chordoma
Conditions
Interventions
Experimental group:Camrelizumab and Apatinib
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent before the implementation of any test related process; 2. It was confirmed as chordoma by histopathology, and there were recurrent or progressive lesions confirmed by two enhancedMRI or PET-CT examinations within 6 months before treatment (according to Choi standard); 3. Patients with refractory chordoma, with or without pulmonary metastases, who are ineligible for surgery or cannot be cured by surgery and/or radiotherapy; 4. Aged >= 18 years old and = 1.5 x 10^9, platelet count >= 80 x 10^9, hemoglobin >= 90g /L (no history of blood transfusiorwithin 7days); (2) Total bilirubin level = 60 ml/ min (Cockcroft Gault formula); (4) Serum albumin >=30 g/L; (5) Thyroid stimulating hormone (TSH) <= 1 x ULN (if abnormal, fT3 and FT4 levels should be examined at the same time, if FT3 and FT4 levels are normal, they can be included in the group). 9. Women of childbearing age must have negative pregnancy test (serum or urine) results within 7 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and 8 weeks after the last treatment; for men, it should be surgical sterilization, or agree to use appropriate contraceptive methods during the observation period and 8 weeksafter the last treatment.
Exclusion criteria
Exclusion criteria: 1. Those who are currently participating in the intervention clinical research, or have received other research drugs within 4 weeks before the first administration: those who have received VEGFR inhibitors, such as sorafenib and sunitinib: those who are currently participating in the intervention clinical research; 2. The patient had received other anti-pD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1, or had received apatinib before; 3. Known allergic reactions to other monoclonal antibodies, active ingredients of apatinib and or any excipients; 4.The patient is using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose >10mg / day prednisone or other therapeutic hormones), and continues to use it within 2 weeks before enrollment, 5. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitilal pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma in childhood has been completely relieved, adults do not need any intervention can be included; patients need bronchitis The patients with asthma treated with dilators could not be included; 6. There are dinical symptoms or diseases that can not be well controlled, such as: (1) Heart failure of NYHA grade 2 or above; (2) Unstable angina pectoris; (3) Myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; (5) QTc>450MS(male);QTc>470 MS(female); and 7. Arteriovenous thrombosis events occurred in the first 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc; 8. They have hypertension and cannot be well controlled by antihypertensive drugs (sytolic blood pressure >= 140 mmHg or diastolic blood pressure>=90 mmHg); 9. Urine routine examination showed that urine protein was >= +, and 24-hour urine protein was more than 1.0g; 10. Patients with abnormal coagulation function (INR > 2.0, Pt > 165), bleeding tendency or receiving thrombolytic or anticoagulant therapy were allowed to use low-dose aspirin and low molecular weight heparin; 11. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia,etc.): 12. Not fully recovered from toxicity and / or complications caused by any intervention (i.e. 2000 1U / ml (or 10^4 copies / ml); HCV RNA > 10^3 copies / ml; or HBsAg + and anti HcV antibody positivepatients; 17. Live vaccine should be inoculated within 30 days before the first administration; note: it is allowed to receive injectable inactivated virus vaccine against seasonal infuenza; however, it is not allowed to receive intranasal live attenuated infuenza vaccine; There are medical history, disease, reatment or laboratory abnormal results that may interfere with the test results and prevent the subjects from participating in the whole study, or the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Progression free survival, PFS;6-month progression free survival (PFS);Overall survival, OS;Disease Control Rate, DCR;Duration of Response, DOR;Quality of life, QoL;Adverse Events; | — |
Countries
China
Contacts
Public ContactCheng Yang/Jianru Xiao
Shanghai Changzheng Hospital
Outcome results
None listed