Initially unresectable non-small cell lung cancer patients
Conditions
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged from 18 to 70, male or female; 2. Patients with lung cancer confirmed by histology or cytology had measurable tumor lesions (spiral CT scan >= 10 mm, meeting the mrecist 1.1 standard); 3. Subjects with positive pleural biopsy or confirmed pleural metastasis or pleural effusion exfoliated cells by PET-CT; 4. Subjects without distant metastasis; 5. Subjects who had not received anti-tumor therapy for lung cancer before operation, including chemotherapy and local treatment; ECoG PS: 0-1; 7. Subjects whose functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period): (1) Neutrophil count >= 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, hemoglobin >= 9 g / dl, serum albumin >= 2.8 g / dl, and serum albumin >= 1.5 x 10^9 / L; (2) Thyroid stimulating hormone (TSH) <= 1 fold ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group); (3) Bilirubin <= 1.5 fold ULN, ALT and AST <= 5 fold ULN; (4) Serum creatinine <= 1.5 fold ULN. 8. Subjects with an estimated survival time of more than 3 months; 9. Patients with non-surgical sterilization or women of childbearing age need to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment period; women of childbearing age with non-surgical sterilization must be negative in serum or urine HCG test within 72 hours before the study; they must be in non lactation period; for men, they should be surgical sterilization or agree to be in the trial Appropriate contraceptive methods were used during the period and within 3 months after the last administration of the trial drug; 10. The subjects who voluntarily joined this study signed the informed consent form (ICF) with good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors in the past or at the same time, excluding fully treated non melanoma skin cancer, cervical carcinoma in situ and papillary thyroid cancer; 2. Patients with active hepatitis B or C (hepatitis B: HBsAg positive and HBV-DNA >= 10 Copies / ml; hepatitis C: HCV antibody and HCV-RNA positive, need antiviral therapy at the same time); 3. Subjects with active tuberculosis infection. Patients with active pulmonary tuberculosis infection within one year before medication should be excluded even if they have been treated; patients with active pulmonary tuberculosis infection more than one year before medication should also be excluded, unless it is proved that they have received standard anti tuberculosis treatment before. 4. Patients with active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilators). Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) who do not need systemic therapy can be included. 5. Patients with previous interstitial lung disease or (non infectious) pneumonia who need oral or intravenous steroid therapy. 6. Subjects with poorly controlled heart disease, such as: (1) New York Heart Association (NYHA) heart failure grade 2 or higher (2) Unstable angina pectoris (3) Myocardial infarction occurred within 1 year (4) Supraventricular or ventricular arrhythmias with clinical significance and requiring treatment or intervention; 7. Known previous allergy to macromolecular protein preparations or any component of karelizumab; 8. Subjects with active infection requiring systemic treatment. 9. Human immunodeficiency virus (HIV, HIV 1 / 2 antibody) positive subjects. 10. Subjects who received or will receive live vaccine within 30 days before administration of karelizumab. 11. Subjects with a history of psychotropic substance abuse, alcoholism or drug abuse. 12. Other factors that may affect the safety of the subjects or the compliance of the test according to the judgment of the researchers. For example, serious diseases (including mental illness), serious laboratory abnormalities, or other family or social factors that need to be treated together.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Complete remission rate;Disease free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactJunfeng Wang
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed