advanced recurrent and metastatic solid tumors
Conditions
Interventions
intervention group:immunotherapy combined with local hypofractionated radiotherapy, GM-CSF and thymosin a1
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, gender is not limited. 2. diagnosed with advanced solid cancer with multiple metastases, progressed after at least first-line chemotherapy recommended by the NCCN guidelines, and have at least three measurable tumor lesions (>1 cm); 3. Acceptable hematopoietic function and general condition ((1) white blood cells >2.5×10^9/L, (2) platelets >50×10^9/L, liver function glutamic pyruvic transaminase and glutamic-oxaloacetic transaminase not exceeding 2.5 times the normal upper limit); 4. There may be stable brain metastases before enrollment, but they are not included in the statistics of measurable lesions; bone metastases without soft tissue formation can be included in the group but not as measurable lesions. 5. Eastern Cooperative Oncology Group (ECOG) score of 0-1 and life expectancy of more than three months; 6. No history of immune diseases; 7. Abide by the plan during the study period; 8. Sign written consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients diagnosed with other malignant diseases in the past five years, except for cured skin cancer and cervical carcinoma in situ; 3. The clinical severity of uncontrolled epilepsy, central nervous system disease, or mental disorder may hinder the signing of informed consent or affect the patient's compliance with medication. 4. Severe (e.g., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months; 5. Organ transplantation requires immunosuppressive therapy; 6. Known major active infections, or significant blood, kidney, metabolism, gastrointestinal, endocrine or metabolic disorders, or other uncontrolled severe concomitant diseases judged by the researchers; 7. The baseline blood routine does not meet the following criteria: hemoglobin (>= 70g/L); absolute neutrophil count (ANC) (>= 1.0 x 10^9/L); platelet (> 50 x 10^9/L); ALT, AST ( <= 2.5 times normal upper limit value); 8. Anaphylaxis to any research drug ingredients. 9. Patients with a history of immunodeficiency, including HIV positive or with other acquired or congenital immunodeficiency disorders, or with a history of organ transplantation, or with other immune-related diseases requiring long-term oral hormone therapy; 10. In the period of acute and chronic tuberculosis infection (T-spot test positive, chest X-ray suspicious tuberculosis focus patients); 11. Other situations which are not suitable for enrollment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 2-year Overall Survival;Objective response rate;Grade of adverse events; | — |
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Countries
China
Contacts
Public ContactXia He
Outcome results
None listed