lung squamous cell carcinoma
Conditions
Interventions
1:KL-A167
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Cytological or histological diagnosis of lung squamous cell carcinoma; 2. Agree to collect the histological specimens of tumors needed in this study and apply them to relevant research; 3. Untreated and resectable squamous cell carcinoma of the lung must have a diameter greater than or equal to 2 cm. 4. Patients who agree to receive radical surgery; 5. Thoracic surgeons judge patients without surgical contraindications. 6. At least one measurable lesion (RECIST V1.1); 7. Male or female (=18 years old) and (=75 years old); 8. ECOG score was 0. 9. Important organs and bone marrow functions meet the following requirements: (a) Blood routine: absolute neutrophil count (ANC)= 1.5 *10^9/L, platelet (PLT) = 100 *10^9/L, hemoglobin (HGB) = 9g/dL; (b) Liver function: serum total bilirubin (TBIL) = 1.5 times normal upper limit (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2.5 times ULN, serum albumin (ALB) =2.8 g/dL; C) Renal function: serum creatinine (Cr) is less than 1.5 x ULN, or creatinine clearance rate is more than 40 ml/min (using standard Cockcroft-Gault formula, see Annex 4 for details); 10. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and within 90 days after the last treatment (see Annex 5 for specific contraceptive measures). 11. Sign a written informed consent and be able to comply with the programme's visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Previous anti-cancer treatments, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine (except for malignant tumors which had been radically cured and had no recurrence or metastasis for more than 5 years); 2. Immunosuppressive drugs were used within 4 weeks prior to the first dose of the study, excluding local glucocorticoids or systemic glucocorticoids (i.e. no more than 10 mg/prednisone or other glucocorticoids of equivalent dose) through nasal spray, inhalation or other routes. 3. Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (Vitiligo or childhood asthma has been completely alleviated, adults without any intervention can be enrolled in the group; Type I diabetes patients with good insulin control can also be enrolled in the group); 4. Known allograft organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 5. Allergy to any component of monoclonal antibody; 6. He/she is suffering from interstitial lung disease; 7. To suffer from other serious uncontrolled diseases, including but not limited to: 1) Severe infections at active stage or under clinical control; 2) HIV infected persons (HIV antibody positive); 3) Patients with acute or chronic active hepatitis B (HBsAg positive and HBV DNA > 1*10^3/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive); 4) Active pulmonary tuberculosis, etc. 5) Class III-IV congestive heart failure (New York Heart Association Classification), poorly controlled and clinically significant arrhythmias; 6) Uncontrolled arterial hypertension (systolic pressure (=160 mmHg) or diastolic pressure (= 100 mmHg); 7) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before admission. 8) Diseases requiring anticoagulant therapy with warfarin (coumarin); 9) Uncontrolled hypercalcemia (more than 1.5mmol/L of calcium or more than 12mg/dL of calcium or more than ULN of serum after correction), or symptomatic hypercalcemia requiring continued bisphosphate therapy; 10) It is accompanied by other malignant tumors (except those cured, such as cervical carcinoma in situ, non-melanoma skin cancer, etc.). 8. Other acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the following results: increasing the risk associated with participating in research or drug administration, or interfering with the interpretation of research results, and classifying patients as not eligible to participate in this study according to the judgement of researchers; 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;RR;OS;MPR; | — |
Countries
China
Contacts
Public ContactShugeng Gao
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed