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Clinical Trials/CTRI/2024/02/063096
CTRI/2024/02/063096
Not yet recruiting
未知

Metabolic response by FDG PET-CT and its correlation with pathological response and genomic profile in patients of Non-Small Cell Lung Cancer (NSCLC) receiving neoadjuvant chemoimmunotherapy - NI

AIIMS New Delhi0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Sponsor
AIIMS New Delhi
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational

Investigators

Sponsor
AIIMS New Delhi

Eligibility Criteria

Inclusion Criteria

  • Age 18\-75 years Pathological diagnosis of NSCLC in Stage 2B or 3A . Being considered for neoadjuvant chemotherapy followed by surgery after discussion in MDT. Complete surgical removal should be deemed achievable including surgical fitness. ECOG (Eastern Cooperative Oncology Group) performance score 0to1\. Adequate organ functions and marrow functions as described below
  • A. Serum creatinine less than equal to 1\.5 mg or creatinine clearance more than equal 50 ml/min. B. Serum Bilirubin less than 1\.5 UNL, ASTor ALT less than 3 UNL C. Hb more than 10\.0 gmdl, Platelet counts more than 100 x10 9 L, absolute neutrophil count more than 1\.5 X10 9L Able to understand the PIS (patient information sheet and give informed consent)

Exclusion Criteria

  • ECOG performance score more or equal to 2 .Harboring EGFR mutations, ALK and ROS1 rearrangements.Prior exposure to immune checkpoint inhibitors. Pre\-existing autoimmune condition requiring systemic immunosuppression including steroids (more than 10 mg Prednisolone equivalent).
  • Acquired immunosuppression (HIV, systemic immunosuppression)
  • .Hematopoietic or organ transplant recipient. History of any other malignancy in past or synchronous malignancy.Pregnant and lactating mothers. Willing to afford or have access to immunotherapy outside study.Patients with any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or compromise the patient’s ability to participate in this study.Uncontrolled diabetes mellitus with fasting plasma glucose persistently above 200 mgdl which could compromise the patient’s ability to undergo FDG PET\-CT scan.

Outcomes

Primary Outcomes

Not specified

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