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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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;

Disqualifiers

Patients with unknown histopathological type were excluded;

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

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

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

Trial population

Patients with advanced non-small cell lung cancer receiving first-line immunotherapy at high and low altitudes

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • High altitude

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Efficacy of first-line immunotherapy for advanced non-small cell lung cancer at high and low altitudes

The evaluation indicators included progression-free survival(PFS), overall survival(OS), objective response rate(ORR), and disease conrtol rate(DCR)

Time frame
2024/10/1-2025/3/31:Data Collection;2025/4/1-2025/6/3:Preliminary analysis;

Secondary outcomes

1

Immune-related adverse reactions in patients with non-small cell lung cancer receiving first-line immunotherapy at high and low altitudes

Type and severity of immune-related adverse effects

Time frame
2024/10/1-2025/3/31:Data Collection;2025/4/1-2025/6/3:Preliminary analysis;

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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