Ib-IIIb NSCLC
Conditions
Brief summary
To observe and evaluate the efficacy and safety of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC and the relevance with Immune Receptor Repertoire
Interventions
DRUGDuvalizumab
Pemetrexed 850 mg, IV, Day1; Platinum 50mg / m2, IV, day1, once every 3 weeks, duvalizumab treatment, 1500mg, day1, a total of 4 cycles, once every 3 weeks. 4 cycles in total
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥ 18 years old; 2. NSCLC confirmed by histopathology; 3. According to the doctor's advice, according to the routine diagnosis and treatment process, lung cancer patients who need radical resection and neoadjuvant therapy before operation; 4. No previous treatment for esophageal cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy; 5. ECoG score was 0 or 1; 6. There was no operative contraindication in preoperative organ function examination; 7. At least 6 months of expected survival 8. The laboratory examination met the following standards: 1. Bone marrow function: hemoglobin (HB) ≥ 90g / L; White blood cell count (WBC) ≥ the lower limit of normal value; Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L； Platelet count ≥ 90 × 10\^9/L； 2. Renal function: Cr ≤ unl (upper limit of normal value) × 5, CCR ≥ 55ml / min; 3. Liver function: total bilirubin ≤ ULN × 1.5； ALT and AST ≤ ULN × 2.5 (patients with liver metastasis can be relaxed to ≤ 5 \* ULN); 4. Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 5, and partial thromboplastin time was within the normal range; 9. The subjects agreed and voluntarily signed the informed consent
Exclusion criteria
1. Allergic to the study drug; 2. History of hemorrhagic disease or with hemorrhagic disease 3. Liver and kidney dysfunction; 4. Patients with uncontrolled diseases (including but not limited to: active infection, symptomatic congestive heart failure; Myocardial infarction occurred within 3 months; Unstable angina, arrhythmia, etc.); 5. Women of childbearing age are unwilling to use contraception; 6. Lactating women; 7. For any other reason, the researchers consider it inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | at 64th week | Objective response rate |
| DFS | at 64th week | disease free survival |
Contacts
Primary ContactXiaorong Dong, PhD
Outcome results
None listed