Lung Cancer
Conditions
Interventions
experimental group:Tianfu thoracic perfusion combined with sindillizumab + chemotherapy, every 3 weeks (21 days) for a treatment cycle
Sponsors
Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male and female; 2. A written informed consent must be signed voluntarily and must be willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study. 3. The Eastern Cancer Collaboration (ECOG) Physical Fitness score is 0 or 1. 4. Expected survival = 3 months. 5. Metastatic (Stage IV) non-squamous NSCLC is histologically or cytologically proven according to the International Association for the Study of Lung Cancer and the Joint American Committee on Cancer Classification, 8th Edition TNM Stage Classification of Lung Cancer. 6. Subjects must be able to provide previous EGFR and ALK reports based on tissue or blood tests that are negative for EGFR insensitive mutations, ALK fusions, and ROS1 fusions. 7. According to RECIST v1.1, the subject must have at least one measurable lesion. 8. Good organ function a) Hematology: (No blood component and cell growth factor support therapy is allowed within 7 days prior to initial administration) : i. Absolute value of neutrophil ANC = 1.5 ×109/L (1,500/mm3); ii. Platelet count = 100 ×109/L (100,000/mm3); iii. Hemoglobin = 9.0g/dL. b) Kidney: i. Creatinine clearance * (CrCl) calculated value =50 mL/min * The Cockcroft-Gault formula will be used to calculate CrCl (Cockcroft-Gault formula) CrCL (mL/min) = {(140 - age) × weight (kg) × F}/ (SCr (mg/dL) ×72) Male F=1, female F=0.85; SCr= serum creatinine. ii. Urinary protein < 2+ or 24-hour (h) urinary protein quantity < 1.0 g. c) Liver: i. Serum total bilirubin (TBil) = 1.5×ULN; ii. AST and ALT = 2.5 x ULN; For subjects with liver metastasis, AST and ALT=5×ULN iii. Serum albumin (ALB) =28 g/L d) Coagulation function: i. International Standardized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 ×ULN (unless subject is receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening). e) Cardiac function: left ventricular ejection fraction (LVEF) =50%. 9. Female subjects with fertility must undergo urine or serum pregnancy test within 3 days prior to the first medication (if the urine pregnancy test result cannot be confirmed as negative, serum pregnancy test is required, the serum pregnancy result shall prevail), and the result is negative. If a fertile female subject has sex with an unsterilized male partner, the subject must use an acceptable contraceptive method since screening and must consent to continued use of the contraceptive method for 120 days after the last administration of the study drug; Whether to stop contraception after this time point should be discussed with the investigator. 10. If an unsterilized male subject has sex with a fertile female partner, the subject must use an effective contraceptive method from the beginning of screening until the 120th day after the last dose; Whether to stop contraception after this time point should be discussed with the investigator; About whether to stop contraception after this point; This should be discussed with the researcher. 11. Subject is willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. There were small cell carcinoma and squamous cell carcinoma components in the histology. 2. Enroll in another clinical study at the same time, unless it is a follow-up period of an observational (non-intervention) clinical study or intervention study. 3. Received the last systemic antitumor therapy (chemotherapy, immunotherapy, biologics, etc.) within 3 weeks before the first dose; Received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to initial administration; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 1 week prior to the first administration. 4. Subjects who continue to use PD-1/L1 inhibitors after the first imaging disease progression on previous PD-1/L1 inhibitor treatment and after the disease progression is confirmed by the next tumor evaluation. 5. Previously received other immunotherapy other than PD-1/L1 inhibitors, including other immune checkpoint inhibitors (such as anti-CTLA-4 antibody, anti-CD47 antibody, anti-SIRP-a antibody, anti-LAG-3 antibody, etc.), immune checkpoint agonists (such as: ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of action of tumors. 6. Patients with active malignancies other than squamous NSCLC within the 3 years prior to enrollment. Subjects with other malignancies that have been cured by local treatment, such as basal or skin squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast, are not excluded. 7. Have an active autoimmune disease that has required systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressive agents) (excluding irAE with PD-1/L1 inhibitors). Replacement therapy (such as thyroxine/insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment. 8. Active or have a clear history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). 9. History of immune deficiency; HIV antibody test positive; Systemic corticosteroid hormones or other immunosuppressants are currently being used on a long-term basis. 10. Subjects with known active tuberculosis (TB) and suspected active TB should be ruled out by clinical examination; Known active syphilis infection. 11. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 12. There is a history or current presence of noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy. 13. Severe infection occurring within 4 weeks prior to initial dosing, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within two weeks prior to initial dosing. 14. Subjects with untreated active hepatitis B (defined as HBsAg positive with more than 1000 copies /ml (200 IU/ml) of HBV-DNA or higher than the lower limit of detection, whichever is higher). For subjects with hepatitis B, anti-hepatitis B therapy is required during study treatment. Active hepatitis C subjects (HCV antibody positive with HCV-RNA levels above the lower limit of detection).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of remission;disease control rate;TTR;progression-free survival;Overall survival;Changes in the properties of pleural effusion (tumor markers, glucose, protein, lactate dehydrogenase, color, etc.); | — |
Countries
China
Contacts
Public ContactMeng Xiangjiao
Affiliated Cancer Hospital of Shandong First Medical University
Outcome results
None listed