A Prospective, Single-arm, Observational Clinical Study Based on 18F-FDG PET/CT to Evaluate the True Efficacy and Immune Response of PD-1 Monoclonal Antibody Combined With First-line Chemotherapy in Advanced Non-small Cell Lung Cancer

Status: Unknown
Location: See location...
Study Type: Observational
SUMMARY

This study is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and received 18F-FDG PET/CT imaging before treatment, after 2 courses of treatment, and at the time of disease progression.At the same time, the blood routine, liver and kidney function, inflammatory indexes and other laboratory data of the subjects participating in the study were collected. Based on 18F-FDG PET Ipercist standard and comprehensive laboratory indicators, the subjects were evaluated for tumor biological characteristics prediction and clinical staging, PD-1 immune efficacy monitoring and evaluation, tumor recurrence monitoring and re-staging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated in order to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.This study plans to set the sample size as 50 cases.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Adult patients (age 18 or above), gender unlimited;

• Pathological diagnosis of non-small cell lung cancer stage IIIB or above;

• Agree to carry out the standard first-line chemotherapy combined with immunosuppression established in this study;

• Consent to 18F-FDG PET/CT imaging and related laboratory examination before and during treatment;

• The patients themselves or their legal representatives are aware of this study and can sign the informed consent.

Locations
Other Locations
China
China, Hubei Province
RECRUITING
Wuhan
Contact Information
Primary
Xiaoli Lan, PhD
lxl730724@hotmail.com
0086-027-83692633
Time Frame
Start Date: 2021-06-01
Completion Date: 2023-06-01
Participants
Target number of participants: 50
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov