osteosarcoma
Conditions
Interventions
Case series:CTC multi-antigen activated immune cells
Sponsors
Shanghai 6th People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, sign an informed consent form, and follow up with good compliance; 2. Pathology or cytology was diagnosed as osteosarcoma. There are measurable lesions that meet the RECIST 1.1 standard. Patients who have not received systematic treatment before, or who have benefited from anthracycline treatment and have had relapse or metastasis more than six months after withdrawal. The last treatment for patients who had received adjuvant or new adjuvant treatment(including chemotherapy, radiotherapy and/or chemotherapy) for past soft tissue sarcoma must be completed at least six months before the first study treatment. Subjects were allowed palliative radiotherapy but had to complete it two weeks before the first study; 3. Aged 18 to 70 years old men and women; 4. The eastern tumor cooperative group(ECOG) scored 0-1; 5. Life expectancy & GT; Twelve weeks; 6. No surgical treatment of target lesions or patient refusal to perform surgery; 7. In the last six months, no anthracene ring chemotherapy was used; 8. Target drugs such as mTOR inhibitors, Teluokai / Kaimeina and deactivated for more than 1 month have been used in the past; Patients who have previously used a similar mechanism to Apatinil but have less than 2 weeks of use and have been deactivated for more than 1 month; 9. Main organ function meets the following criteria within 7 days prior to treatment: (1) Standard for routine screening of blood(in the absence of blood transfusion within 14 days prior to screening): hemoglobin(HB) = 90 g/L; The absolute value of neutrophils(ANC) = 1.5 × 10^9/L; Platelets(PLT) = 80 × 10^9/L; (2) The biochemical examination shall meet the following criteria: Total bilirubin(TBIL) = 1.5 times the upper limit of normal value(ULN); Alanine aminotransferase(ALT) and aspartic acid aminotransferase(AST) = 2.5 ULN, if associated with liver metastasis, then ALT and AST = 5 ULN; Serum creatinine(Cr) = 1.5 ULN or creatinine clearance(CCr) = 60 ml/min. 10. Women of childbearing age should agree to use contraception(such as intrauterine devices, contraceptives or condoms) during the study and within six months of the conclusion of the study; The serum or urine pregnancy test was negative within 7 days before the study and must be a non-lactating patient; Men should agree with patients who have to use contraception during the study period and six months after the study period.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension who still can not maintain stability through regular blood pressure reduction treatment, suffer from = II coronary heart disease, arrhythmias(including QTc interphase extension, males > 450 MS, females > 470 MS) and cardiac dysfunction; 2. Have a variety of factors that affect oral drug absorption(such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. Special attention: Patients with gastrointestinal bleeding risk can not enter the group, including the following situations:(1) active digestive ulcer lesions, and stool latent blood(+ +); (2) Those with a history of black stool and vomiting blood within 3 months; (3) A gastroscopic examination must be performed on the latent blood(+) of stool to determine whether there is an organic disease of the gastrointestinal tract; 4. Inclotting dysfunction(INR & GT; 1.5 × ULN, APT T & GT; 1.5 × ULN), with bleeding tendency; 5. People who are allergic to any component of this product should be banned; 6. Active hemorrhage, 30 days after major surgery; 7. Intracranial metastasis; 8. Pregnant or lactating women; 9. Other malignant neoplasms in the past three years; 10. Giant metastasis / recurrent lesion, and imaging suggests that necrotic tissue is the main lesion; 11. Malignant pleural effusion or peritoneal effusion, causing NCI CTCAE grade 2 or above breathing difficulties; 12. The researchers believe that there are any conditions that may harm the subject or cause the subject to fail to meet or perform the research requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFR;PFR; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai 6th People's Hospital
Outcome results
None listed