advanced malignant solid tumors
Conditions
Interventions
experimental group:PD-1 inhibitor combined with NK cells
Sponsors
Department of Oncology, Xiang’an Hospital of Xiamen University, Xiamen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients are diagnosed as advanced malignant solid tumors with definite pathological and CT imaging evidence. 2) Select patients with indications to use PD-1 immunosuppressive agents: PD-L1 expression level is greater than 5%, positive combined score (CPS) is greater than 10%, microsatellite instability is high, or tumor mutation burden (TMB) is greater than 10 mut/Mb. 3) There must be at least one evaluable lesion judged by the iRECIST V1.1 standard; 4) Male or female, aged 18-75 years; 5) Karnofsky score >= 80; 6) The expected survival period is >= 3 months; 7) Subjects who agree to participate in the clinical trial voluntarily and sign the informed consent form, with good compliance. 8) The main organs are functioning normally and meet the following standards: Blood routine: HB >= 90g/L (no blood transfusion or EPO dependence within 14 days); ANC >= 1.5 x 10^9/L; PLT >= 100 x 10^9/L; Blood biochemistry: TBIL = 60ml/min; Urine routine examination: urine protein is less than 2+, or 24-hour urine protein quantitative = the lower limit of normal (50%).
Exclusion criteria
Exclusion criteria: 1) Those who are less than 18 years old or more than 75 years old; 2) Patients who have received chemotherapy, radiotherapy, biological therapy, targeted therapy, immunotherapy and other anti-tumor therapy within 4 weeks before using the research drug for the first time; 3) Patients who have received other clinical trial treatments within 4 weeks before using the study drug for the first time; 4) Patients who received major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before using the study drug for the first time; 5) Patients who have received systemic corticosteroids (prednisone > 10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first use of the study drug, except for the following patients: use of topical, ocular Intra-articular, intranasal and inhaled corticosteroid therapy; short-term use of corticosteroids for preventive treatment (such as prevention of docetaxel, contrast agent allergy); 6) The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade evaluation 480ms; acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events above grade III within 6 months; New York Heart Association (NYHA) new function classification >= Grade II or left ventricular ejection fraction (LVEF) < 50%; uncontrollable hypertension. 12) Patients with active, or have had autoimmune diseases that may have recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); patients with clinically stable autoimmune thyroiditis are excluded. 13) People with mental disorders or poor compliance; 14) Women during pregnancy or lactation; 15) The researcher believes that the subject has other serious systemic diseases or other reasons and is not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate;duration of response;objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Progress Free Survival; | — |
Countries
China
Contacts
Public ContactHanxiang An; Tao Chen
Department of Oncology, Xiang'an Hospital of Xiamen University, Xiamen University
Outcome results
None listed