pulmonary sarcomatoid carcinoma
Conditions
Interventions
experimental group:Pre-surgical neoadjuvant therapy phase
1.Adebrelimab: 1200 mg IV, D1, Q3W, treatment for 2-4 cycles
2. Apatinib: 250 mg, QD, half hour after meal, treatment for 2-4 cycles
3. albumin paclitaxel: 260 mg/m2, D1, Q3W
4. cisplatin: 70 mg/m2, D1, Q3W (no more than 130 mg)/carboplatin: 300-400 mg/m2, D1, Q3W.
Chemotherapy may be given in split doses before and after surgery for a total of no more than 4 cycles of tre
adjuvant treatment with TKIs is selected by the investigator for driver gene-positive patients).
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and = 75 years; 2. Histologically proven inoperable pulmonary sarcomatoid carcinoma, or patients with surgically resectable pulmonary sarcomatoid carcinoma (according to the WHO criteria for pulmonary sarcomatoid carcinoma, pathology specimens containing spindle and/or giant cells, pleomorphic carcinoma, giant cell carcinoma, carcinosarcoma, and pneumoblastoma components) If the patient has a diagnosis of non-small-cell lung carcinoma with a sarcomatoid component in the biopsy sample, the tumor cells of the sarcomatoid component may be spindle, and/or giant cellular and/or heterologous sarcoma differentiation, including rhabdomyosarcoma, chondrosarcoma, and so forth, may be included; and or giant cells and/or heterologous sarcomatous differentiation, including rhabdomyosarcoma, chondrosarcoma, etc., may also be included; 3. Exclude patients with exon 14 jump mutations in the MET gene; 4. No prior immunosuppressive and antivascular therapy against PSC tumors; 5. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1; 6. Patients must have at least one measurable lesion according to RECIST 1.1 criteria; 7. Must provide sufficient tumor tissue samples (puncture biopsy/fresh/wax-embedded) with a diagnosis of pulmonary sarcomatoid carcinoma, as well as blood samples during treatment for biomarker exploration including, but not limited to, PD-L1 immunohistochemical staining, and NGS testing; 8. Subjects must have adequate lung function for the anticipated lung resection; 9. Good hematopoietic function, defined as absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L, and hemoglobin = 90g/L [no transfusion or no erythropoietin dependence within 7 days]; 10. Good hepatic function, defined as total bilirubin level = 1.5 times the upper limit of normal (ULN); albumin transaminase (AST) and alanine aminotransferase (ALT) levels = 2.5 times the ULN in patients with no hepatic metastases; AST and ALT levels = 5 times the ULN in patients with documented hepatic metastases; 11. Good renal function, defined as serum creatinine = 1.5 times ULN or calculated creatinine clearance = 60 ml/min (Cockcroft-Gault formula); urine protein of less than 2+ on routine urinalysis, or if the patient has urinary protein of = 2+ at baseline level 24-hour urine should be collected and demonstrated to be = 1g on a 24-hour quantitative urine protein test; 12. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 times the ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the range of use of anticoagulant medication proposed; 13. For female subjects of childbearing potential, a serum pregnancy test shall be performed within seven days prior to receiving the first test drug administration (Cycle 1, Day 1) with a negative result. 14. Subjects must agree to use an effective method of contraception or have been surgically sterilized for the duration of the trial and for 90 days after the last administration of the test drug; 15. Be able to comply with study and follow-up procedures; 16. Signed written informed consent prior to the implementation of any trial-related processes.
Exclusion criteria
Exclusion criteria: 1. Patients with prior use of anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs acting on T-cell co-stimulation or checkpoint pathways (e.g., OX40, CD137, etc.), or prior use of anti-angiogenic drugs; 2. Imaging (CT or MRI) showing confirmed tumor invasion of large blood vessels or poor demarcation from blood vessels, and a single hemoptysis = 2.5mL within 1 month prior to the first dose; 3. Patients with exon 14 jump mutation of MET gene; 4. With active bleeding or perforation or the presence of hereditary or acquired bleeding tendency; 5. Patients with hypertension who cannot be reduced to the normal range (systolic blood pressure = 140 mmHg / diastolic blood pressure = 90 mmHg) by antihypertensive drug treatment; 6. Urine routine suggests that urinary protein = (++), and the amount of urinary protein in 24 hours = 1.0g; 7. Presence of thrombotic diseases requiring long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy (aspirin = 300 mg/day or clopidogrel = 75 mg/day); 8. Have multiple factors that interfere with the absorption of oral medications, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction 9. Have symptomatic, untreated or actively progressing central nervous system (CNS) metastases confirmed by CT or MRI evaluation during screening and prior to radiologic imaging evaluation. However, asymptomatic patients with stable CNS lesions that have been treated may also be enrolled as long as all of the following conditions are also met: (i) Measurable lesions identified according to RECIST v1.1 must exist outside the CNS; (ii) Patients have no history of intracranial or spinal cord hemorrhage; (iii) Patients have not had stereotactic radiation therapy within 7 days prior to initiation of study treatment, whole brain radiation therapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment; ? Imaging confirmation of stabilization for at least 4 weeks prior to enrollment and cessation of systemic hormone therapy (dose = 10 mg/day prednisone or other equivalent hormone) for > 2 weeks; ? Metastases are limited to the cerebellum or supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord); 10. Currently participating in an interventional clinical study treatment or have received other investigational drugs or have been treated with an investigational device within 4 weeks prior to the first dose; 11. Has received a solid organ or blood system transplant; 12. Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids used for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy; 13. Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study; physiologic doses of glucocorticoids (= 10 mg/day of prednisone or equivalent) are allowed; 14. Have history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to the first dose of glucocorticoid therapy 15. Subjects with g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The surgical conversion rate ;Objective Response Rate;Major pathological response after;Disease Control Rate;Disease-Free Survival;Event-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactJun Chen
Tianjin Medical University General Hospital
Outcome results
None listed