Non-small cell lung cancer
Conditions
Interventions
A:Iodine-125 in combination with PD1 monoclonal antibody and Docetaxel injection
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed non-small cell lung cancer; 2. There is no known to have drive gene positive therapeutic targets, such as EGFR, ALK, mutated BRAF, MET, ROS1, RET, etc.); 3. Patients who have recurred after previously receiving a systemic therapy and have not previously received particle therapy. (including patients who did not relapse more than 6 months after the end of adjuvant therapy) 4. Measurable lesions (according to RECIST 1.1 standards, the CT scan length =10mm for tumor lesions and the short CT scan diameter =15mm for lymph node lesions); 5. General condition score ECOG score 0-1; 6. The expected survival time is more than 3 months; 7. Age =18 years old; 8. Asymptomatic brain metastases or focal control after brain metastases radiotherapy. 9. Bone marrow hematopoietic function is normal: white blood cell count =4×109/L, neutrophil count =2.0×109/L, hemoglobin count =90g/L, platelet count =100×109/L; 10. The heart, lung and other organ functions are basically normal, no serious medical diseases; 11. Patients with potential fertility need to use a medically approved contraceptive method (e.g. IUD, contraceptive pill or condom) during the study treatment period and for one month after the end of the study treatment period; Serum or urine HCG tests must be negative within 72 hours before study entry, and must be non-lactating. 12. Signed informed consent, good compliance, regular follow-up, voluntary compliance with research regulations.
Exclusion criteria
Exclusion criteria: 1.Have participated in other drug trials or other drug treatments within 4 weeks; 2. Serious uncontrolled medical disease or acute infection; 3. The patient has had or co-developed other malignancies within 5 years (except cured basal cell carcinoma of the skin and cervical carcinoma in situ); 4. Pregnant or lactating women; 5. Known allergy to the investigational drug; 6. Subjects had poor control of intractable pleural or pericardial effusion 7. Patients with unsatisfactory blood pressure control (systolic pressure =150 mmHg, diastolic pressure =100 mmHg); Unstable angina pectoris, myocardial infarction, = grade 2 congestive heart failure, or arrhythmias requiring treatment (including QTc=480ms) within 6 months prior to first dosing; 8. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or complete remission of asthma in childhood could be included as adults without any intervention; Patients with asthma requiring medical intervention with bronchodilators were not included); 9. Subjects who are taking immunosuppressants, or systemic, or absorbable local hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks prior to enrollment; 10. Severe infections (CTCAE > Grade 2), such as severe pneumonia requiring hospitalization, bacteremia, and infection complications, occurred 4 weeks prior to the first use of the study drug; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral and intravenous antibiotic treatment, except in cases of prophylactic antibiotic use; 11. The subjects had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled; 12. Patients with grade ? to ? cardiac insufficiency according to NYHA standards, or left ventricular ejection fraction (LVEF) 1.5 APTT>1.5 ULN) and bleeding tendency; 14. Wounds or fractures that have not healed for a long time; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 15. Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA test value exceeds the upper limit of normal); 16. Patients with a history of psychotropic substance abuse who cannot abstain or who have mental disorders. 17. There are situations that other researchers consider unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactQi Zhao
Nanjing Drum Tower Hospital
Outcome results
None listed