Advanced Cancer, Metastatic Cancer
Conditions
Brief summary
The clinical efficacy of chemotherapy /PD-1 monoclonal antibody/targeted therapy, chemotherapy /PD-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia and chemotherapy /PD-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia + autosomatic immunotherapy in the treatment of refractory refractory solid tumors with first-line treatment failure was compared.
Interventions
DEVICEThermotron RF-8EX
Hyperthermia for 40-50 minutes
BIOLOGICALAutologous Adoptive immune cells
Immunotherapy Mononuclear cells were collected from 50ml peripheral blood , and cultured adoptive immune cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion.
DRUGChemotherapy，checkpoint immunotherapy, targeted therapy
The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines
Sponsors
Duke University
Shanghai Pudong Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients previously diagnosed with solid tumor by histopathology and/or cytology; 2. Aged 18 and 80, regardless of gender; 3. ECOG score of general physical condition was 0\ 2; 4. The expected survival time is at least 3 months; 5. Patients with metastatic and recurrent tumors who failed conventional first-line therapy (including those above first-line therapy) and need to change treatment regimens; 6. According to RECIST standards, at least one measurable objective tumor index (spiral CT detection target lesion 10mm); 7. WBC 3.0109 /L Hb 90g/L PLT 75.109 /L at baseline upon enrollment; 8. Normal liver function a) Liver: total bilirubin 2.0 mg/dL(34.2umol/L), 2.5 times the upper limit of AST and ALT, 5 times the upper limit of AST and ALT in patients with liver metastasis b) Kidney: Creatinine 2.5 mg/dL(221umol/L), creatinine clearance rate 60 mL/min; 9. Understand and sign informed consent and voluntarily participate in clinical research
Exclusion criteria
1. severe active infection and other serious complications; 2. Patients with a history of autoimmune diseases, including but not limited to multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, excluding vitiligo; 3. Prednisone can be used in patients with systemic corticosteroid or other immunosuppressive hormone therapy. 0.5 mg/kg/day (maximum cell count group 40 mg/day) or other similar drugs in the same cell count group, inhaled corticosteroids for chronic obstructive pulmonary disease (COPD) or topical administration; 4. patients who have undergone major organ transplants; 5. Patients in the active stage of viral hepatitis; 6. Patients with coagulation dysfunction; 7. have uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia; 8. Pregnant or lactating women. 9. symptomatic brain metastases or mental disorders; 10. Participated in clinical trials of new drugs within 4 weeks before enrollment; 11. If the patients are randomly assigned to the hyperthermia treatment group, they need to refer to the exclusion requirements of hyperthermia (the hyperthermia site contains metal or thermal implant, skin allergy to heat, and body position cannot cooperate). 12. Other factors considered by researchers are not suitable for candidates.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 12 months | Frome the starting date of the enrollment until the date of the first documented disease progression or the date of the death from any cause,whichever comes first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overal survival(OS) | 24 months | Frome the starting date of the enrollment until the date of the death from any cause |
| Safty(adverse events) | 12 months | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Patient-Reported Outcome (PRO) | 24 months | To assess and compare the PRO scores by patients in each group |
Countries
China
Contacts
Primary ContactJun Ren, MD,PhD
Outcome results
None listed