Status:
UNKNOWN
Monitoring the Efficacy of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC by Sequencing of Immune Receptor Repertoire: a Prospective, One Arm Clinical Study
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Ib-IIIb NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Age: ≥ 18 years old;
- NSCLC confirmed by histopathology;
- 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;
- No previous treatment for esophageal cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy;
- ECoG score was 0 or 1;
- There was no operative contraindication in preoperative organ function examination;
- At least 6 months of expected survival
- The laboratory examination met the following standards:
- 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；
- Renal function: Cr ≤ unl (upper limit of normal value) × 5, CCR ≥ 55ml / min;
- Liver function: total bilirubin ≤ ULN × 1.5； ALT and AST ≤ ULN × 2.5 (patients with liver metastasis can be relaxed to ≤ 5 \* ULN);
- Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 5, and partial thromboplastin time was within the normal range;
- The subjects agreed and voluntarily signed the informed consent
Exclusion
- Allergic to the study drug;
- History of hemorrhagic disease or with hemorrhagic disease
- Liver and kidney dysfunction;
- 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.);
- Women of childbearing age are unwilling to use contraception;
- Lactating women;
- For any other reason, the researchers consider it inappropriate to participate in the trial.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04897386
Start Date
June 1 2021
End Date
December 1 2024
Last Update
May 21 2021
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