Bone and soft tissue sarcoma and bone metastasis cancer in new aided and chemotherapy-assisted chemotherapy
Conditions
Interventions
Control group:Receive neoadjuvant or adjuvant chemotherapy
Experimental group:After receiving neoadjuvant or adjuvant chemotherapy, infusion of umbilical cord blood mononuclear cells is given within 24 hours
Sponsors
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years at the time of screening; 2. Before undergoing any chemotherapy regimen for neoadjuvant, adjuvant chemotherapy, bone and soft tissue sarcoma and bone metastasis cancer, subjects with adverse reactions above grade II, including the evaluation of the screening period, obtain written notification from the subject/legal representative agree; 3. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-1; 4. Life expectancy >= 6 months, patients in our department who received neoadjuvant chemotherapy, had adverse reactions above grade II in the last chemotherapy; 5. Cardiopulmonary function is basically normal; 6. Informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. The subject has a central nervous system metastasis with clinical symptoms (such as brain edema, need for hormonal intervention, or progression of brain metastasis). Subjects who have previously received brain or meningeal metastasis therapy, such as clinical stability (MRI) has been maintained for at least 2 months, and have stopped systemic hormone therapy (dose>10mg/day prednisone or other curative hormones) for more than 2 weeks Can be included 2. Subjects are using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 3. Subjects are using immunomodulator drugs and continue to use them within 2 weeks before enrollment; 4. The subject has any active autoimmune disease or a history of autoimmune disease; 5. The subject has active tuberculosis; 6. The subject has hepatitis C or HIV infection, or syphilis infection; 7. According to the judgement of the investigator, the subject has other factors that may lead to the termination, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, and family or social factors. Affect the safety of subjects, or the collection of test data and samples;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Adverse reaction control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade II adverse reactions; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Outcome results
None listed