histologically or cytologically confirmed advanced metastatic (stage IV) non-small cell lung cancer
Conditions
Interventions
experimental group:Toripalimab Combined With Cryoablation
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet all of the following criteria are eligible to participate in the trial: 1. Patients who have signed the informed consent form and are able to comply with the study protocol; 2. Patients with histologically or cytologically confirmed advanced metastatic (stage IV) non-small cell lung cancer; 3. Patients with negative driver genes and oligoprogression after receiving standard first-line therapy, oligoprogression is defined as: a) There are 1~5 metastatic lesions, and up to 3 organs (excluding primary organs) are involved, and the organs involved are all organs except diffuse serosal metastases, and (meninges, pericardium, pleura, mesentery) and bone marrow involvement are allowed; Lung metastases should follow the eighth edition of TNM staging, M1a lesions are counted as one metastatic site, and metastases in the same lung lobe (T3) or in the same lung with primary tumor (T4) are not counted as metastatic sites; After systemic therapy, =18 years old; 5. The performance status score (ECOG PS) of the Eastern Cooperative Oncology Group (ECOG PS) was 0-1; 6. The expected survival time is greater than 12 weeks; 7. Measurable lesions in the baseline period; 8. Adequate hematologic function: absolute neutrophil value (ANC) >=1.5 x 109/L, and platelet count >=80 x 109/L, and hemoglobin >=9 g/dL (can be transfused to maintain or exceed this level) Adequate liver function: total bilirubin =50mL/min, and urine protein =2+ on urine dipstick at baseline, 24-hour urine collection should be performed, and the protein content in the urine within 24 hours must be =12 months) or who have not undergone sterilization surgery (ovarian and/or uterine removal): agree to use contraceptive methods during treatment; 12. For males: agree to use contraceptive methods during the treatment period and for at least 6 months after the last dose of study drug (annual failure rate <1%).
Exclusion criteria
Exclusion criteria: 1.cytologically or histologically confirmed combination with small cell lung cancer component or sarcomatoid element; 2.Previously received targeted therapy for advanced NSCLC (including osimertinib, erlotinib, crizotinib, etc); 3.Had undergone major surgical operations or had not fully recovered from previous operations within 3 weeks before enrollment; 4.Known active nervous system (CNS) metastases and/or carcinomatous meningitis; 5.Spinal cord compression for which operation and/or radical radiotherapy has not been given, or no clinical evidence of stable disease for >= 4 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression; 6.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 7.patients with stable symptoms after drainage can be enrolled; 8.History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active pneumonia during chest CT scanning for screening; 9.Clinically uncontrolled active infection, including but not limited to acute pneumonia; 10.Uncontrollable major epileptic seizure or superior vena cava syndrome; 11.Previous or current co-occurrence of other malignancies (excluding controllable non-melanoma basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast or cervix, superficial bladder cancer, or other carcinoma in situ); 12.Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease; 13.Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening; 14.Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle; 15.Vaccination of live-virus vaccine within 30 days after the start of planned treatment; 16.Inactivated seasonal influenza vaccine was permitted; 17.Patients has HIV-positive; 18.Patients judged by the investigator to be inappropriate as a subject of this study. History of severe allergic, quasi-allergic, or other hypersensitive reactions to chimeric or humanized antibodies or fusion proteins; 19.Known allergy to biological drugs produced from Chinese hamster ovary cells, or to citrate monohydrate, sodium citrate dihydrate, mannitol, polysorbate (components of the study drug); 20.Patients who have previously received allogeneic stem cells or parenchymal organ transplants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Duration of response;overall survival;Treatment Emergent Adverse Event;correlation; | — |
Countries
China
Contacts
Public ContactZiming Li
Shanghai Chest Hospital
Outcome results
None listed