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NCT06730503Recruiting

Glycoprotein in Immunotherapy Response and Efficacy Prediction of Lung Cancer

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

Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
9 Dec 2024
Start date
1 Oct 2023
Primary completion date
31 Oct 2027
Lead sponsor
Shanghai Chest Hospital
Diseases
Lung cancer
NCT number
NCT06730503

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 1 Oct 2023 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with other tumors. Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin or cervical cancer in situ, subjects who have received potential radical treatment and have not relapsed within 5 years before the start of treatment can be included in the study;
  • Have received any approved systemic anti-tumor immunotherapy before starting the research treatment;
  • Known human immunodeficiency virus infection; previous allogeneic stem cell transplantation or organ transplantation;

Other illness

  • A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.;
  • Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;

Other

  • The investigator judged that the patient's compliance during the study period was insufficient.

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xiaomin Niu
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.