A Study on the Efficacy of Immunotherapy, the Occurrence and Severity of Adverse Reactions in Patients with Non-small Cell Lung Cancer in High-altitude Areas

NCT ID: NCT06757114

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-06-30

Brief Summary

As a major disease with high incidence and mortality rate, lung cancer seriously threatens the health of our people and causes a huge burden of disease. In recent years, with the widespread use of immune checkpoint inhibitors (ICIs), great progress has been made in the treatment of lung cancer, which has brought significant survival benefits to patients. Although ICI has greatly improved the prognosis of lung cancer patients, due to the complexity of the mechanism of action of ICI and the heterogeneity within the tumor, the benefit population of treatment is relatively limited, and some patients are still at risk of primary drug resistance and tumor hyperprogression.In this study, we aimed to compare the differences in the efficacy and adverse reactions of immunotherapy in patients with advanced non-small cell lung cancer at high and low altitudes, and to find out the relevant factors from multiple omics such as imaging, pathology, and genetics, so as to solve the problem of immunotherapy resistance

Conditions

Non-small Cell Lung Cancer(NSCLC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

High altitude

High altitude is defined as a long-term residence with an altitude of 1500m and above

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• (1) Patients with primary non-small cell lung cancer (adenocarcinoma/squamous cell carcinoma/adenosquamous cell carcinoma/large cell lung cancer/others) with clear cellular/histopathological evidence; (2) Primary non-small cell lung cancer of any stage receiving immunotherapy for the first time; (3) Patients who have undergone at least 2 cycles of immunotherapy during the treatment period and have undergone one efficacy evaluation; (4) Patients with at least one evaluable target lesion (except for those with uncontrolled brain metastases) according to Response Evaluation Criteria for Solid T Tumors (RECIST, version 1.1); (5) Voluntary participation in research and strong willingness to cooperate; (6) has been residing in Qinghai Province since birth; (7) Have been residing in Shaanxi Province since birth; (8) Be at least 18 years old;

Exclusion Criteria

1. Patients with unknown histopathological type were excluded;

2. Patients with unclear diagnosis and treatment information and immunotherapy-related adverse reactions;

3. Patients with bipolar/multiple primary non-small cell lung cancer with other tumors were excluded;

4. Patients who are unwilling to join the study and have poor willingness to cooperate;

5. Patients who migrated to Qinghai or Shaanxi from different altitudes and had a history of migration between the two provinces were excluded;

6. exclude patients with a history of emigration from parents;

7. Patients who have received immunotherapy for other tumors in the past;

8. Prior immunosuppressive therapy prior to exclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hui Guo, Doctor

Role: CONTACT

guohui@xjtufh.edu.cn

8613572824106

Other Identifiers

（2024）EC-KY（NO.076）

Identifier Type: -

Identifier Source: org_study_id