Sugar Chain Heterogeneity in Immunotherapy Response and Efficacy Prediction of Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Immunotherapy has improved the prognosis of non-small cell lung cancer (NSCLC) patients, but about 80% of patients do not respond at all (primary resistance), and some patients initially respond to immunotherapy, later relapse and develop disease progression (acquired resistance). So the objective of this research is to explore the sugar chain heterogeneity of primary and acquired resistance to immunotherapy in patients with NSCLC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Be able to provide informed consent, and understand and agree to follow the research requirements;

• Advanced non-small cell lung cancer;

• Patients receiving immune checkpoint inhibitor treatment represented by anti-PD-1/PD-L1 monoclonal antibody;

• The patient must be able to provide 10mL peripheral whole blood samples before- and after- ICIs;

• ECOG physical fitness status ≤1;

• The patient must have at least one measurable lesion (assessed according to RECIST v1.1);

• Life expectancy ≥ 12 weeks;

• The patient must have adequate organ function, and must be reached absolute neutrophil count (ANC) ≥1.5x10\^9/L, platelets ≥100x10\^9/L, hemoglobin ≥90g/L, international normalized ratio (INR) or prothrombin time ≤ 1.5x ULN , activated partial thromboplastin time (aPTT)≤1.5x ULN, serum total bilirubin≤1.5x ULN (Patients with Gilbert syndrome can be enrolled if total bilirubin\<3x ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x ULN(Patient with liver metastases, this standard is AST and ALT≤5x ULN) within 7 days before treatment;

Locations
Other Locations
China
Xiaomin Niu
RECRUITING
Shanghai
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 250
Treatments
Anti-PD-1/PD-L1 monoclonal antibody
Sponsors
Leads: Shanghai Chest Hospital

This content was sourced from clinicaltrials.gov