Observational study
Conditions
Interventions
Case series:Toripalimab
Sponsors
The General Hospital of People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) aged >= 18 years; (2) lung squamous cell carcinoma was diagnosed by histology and related examination; (3) it is a resectable tumor; (4) patients who can be operated after preoperative evaluation; (5) did not receive any systematic treatment of lung cancer before participating in the study; (6) TNM was divided into stage IB-?A; (7) ECOG PS score 0-1; (8) the urine pregnancy test of women of childbearing age must be negative. From the beginning of the screening period to the last use of the study drug, fertile women and men must voluntarily use recognized and effective contraceptive measures; (9) be able to read, understand and give written informed consent.
Exclusion criteria
Exclusion criteria: (1) patients with definite stage IV and part of stage III (T4 lesions involving aorta and trachea); (2) patients who have been previously treated with PD-1, PD-L1, PD-L2, CTLA-4, or directly treated with another stimulating or co inhibiting T cell receptor (such as CTLA-4, ox 40, CD137); (3) patients with active autoimmune diseases who need systemic treatment or who have immune deficiency; (4) patients who were vaccinated within 30 days before admission; (5) for patients with serious heart, liver, kidney and other important organs, blood and endocrine system diseases, the evaluation criteria are as follows: 1) heart disease: Patients with decompensated cardiac insufficiency or refractory hypertension (hypertension who can not control systolic and diastolic blood pressure at the target level after sufficient dose, reasonable combination and at least three antihypertensive drugs combined treatment, including lifestyle improvement and diuretic use); abnormal ECG during screening, which is considered clinically significant by the researchers And it may bring unacceptable risk to patients to participate in this study; 2) liver function: alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) >= 2 times of upper limit of normal reference value (ULN); 3) renal function: with renal tubules and / or renal interstitial lesions, or renal insufficiency: blood creatinine >= ULN or glomerular filtration rate (EGFR) < 60ml / min / 1.73m2; 4) WBC < 3 x 10^9 / L and / or HB < 100g / L and / or PLT < 80 x 10^9 / L; (6) patients who participated in another clinical study 4 weeks before or during the study; (7) in the past two years, there are known patients with other malignant tumors other than esophageal cancer that are developing or need active treatment, or are expected to need active treatment within two years; (8) history of previous (non infectious) pneumonia; (9) there are active infections that need to be treated, which can aggravate the disease; (10) patients with HIV or hepatitis B or C; (11) patients who have received organ transplantation; (12) uncontrolled patients with complicated diseases, including but not limited to uncontrolled infection, congestive heart failure, unstable angina, arrhythmia, etc; (13) patients who could not tolerate surgery; (14) patients whose distance from the tumor site to the incisor was less than 23cm; (15) patients who were unable to swallow liquid food or who were unable to take tegio orally were assessed by researchers; (16) pregnant and lactating women, or those of childbearing age who cannot guarantee effective contraception; (17) mental illness or other reasons can not cooperate with the treatment; (18) people with allergic constitution or multiple drug allergy or PD-1 allergy or intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PCR;OS;DFS;ORR;PD-L1 expression;WES;RNA-seq;TCR;safety; | — |
Countries
China
Contacts
Public ContactYang Liu
The General Hospital of People's Liberation Army
Outcome results
None listed