Lung squamous cell carcinoma
Conditions
Interventions
Experimental group:Treatment of Neoadjuvant and Monotherapy with Camrelizumab+Paclitaxel-albumin+Platinum-based Chemotherapy
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years to 70 yearsmale or female. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 3. The life expectancy is not less than 12 weeks. 4. Squamous non-small cell lung cancer confirmed by pathology (histology or cytology) according to the 2015 WHO histological classification of lung cancer. 5. IIB, IIIA and part of IIIB(T3N2M0, T4N2M0)according to UICC and the 8th edition of AJCC/TNM staging system of lung cancer. 6. Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion >= 10 mm, the short diameter of lymph node >= 15mm). 7. Patients who have not received radiotherapy, chemotherapy, surgery or targeted therapy before enrollment. 8. The subject must have sufficient lung function for the intended pulmonary?resection. 9. The main organ function is normal. Screening laboratory values must meet the following criteria. a.Hemoglobin >= 90 g/L;b.Absolute neutrophil count >= 1.5 * 10^9/L ;c Platelets >= 100 * 10^9/L ;d Total bilirubin (TBIL) = 50 mL/minute (using Cockcroft/Gault formula). 10. Female Subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment. Male Subjects with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment. 11. Subjects has voluntarily agreed to participate by giving written informed consent/assent for the trial.
Exclusion criteria
Exclusion criteria: 1. Imaging (CT or MRI) showed the presence of a central tumor that invades the local large vessels. 2. Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone=10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose. 3. Subjects received systemic treatment of Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use for controlling pleural effusion) within 14 days before the first administration. 4. Subjects has the history of other malignancies. 5. Live attenuated vaccine was given 4 weeks before the first administration or during the study period. 6. Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism, decreased thyroid function). 7. The patient has severe infection within 4 weeks before first administration(such as the need for intravenous antibiotics, antifungals or antivirals) and unexplained fever within 7 days before administration, >= 38.5 degrees C. 8. There is evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia and severe impairment of lung function. 9. Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function). 10. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. (HBV: HBsAg positive and HBV DNA >= 500 IU/mL; HVC: HCV RNA positive and abnormal liver function). And subjects with active tuberculosis. 11. Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria. 12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 13. Patients with a clear history of allergies may be potentially allergic to or intolerant to biological agents such as carboplatin, cisplatin, pemetrexed, and carillizumab camrelizumab. 14. The investigator judge that there are any other factors that may damage the subject or cause the subject unable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;ORR;EFS; | — |
Countries
China
Contacts
Public ContactLiu Shuku
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed