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To screen the dominant population of first-line immunotherapy for advanced lung cancer without driver gene mutations based on the immune characteristics of traditional Chinese medicine (TCM) syndrome

To screen the dominant population of first-line immunotherapy for advanced lung cancer without driver gene mutations based on the immune characteristics of traditional Chinese medicine (TCM) syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083646
Enrollment
Unknown
Registered
2024-04-29
Start date
2022-11-09
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Qi and Yin deficiency group:none
Qi deficiency and phlegm-dampness group:none

Sponsors

Tongde Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosed as advanced non-small cell lung cancer after obtaining tissue pathology through lung tissue puncture, surgery, or cytological testing, and no driver gene mutations such as EGFR and ALK were required and clear PD-L1 TPS test results were obtained. 2. PD-L1 immunosuppressant monotherapy or combined with chemotherapy as the first-line treatment; 3. It is qi and Yin deficiency syndrome, qi deficiency and phlegm dampness syndrome or other syndrome types by TCM syndrome differentiation (preliminary screening through tongue diagnosis platform); 4. Age =40, =80 years old; 5. Karnofsky Performance Scale (KPS) =60; 6. Expected survival time =6 months; 7. Good compliance, can understand the situation of this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the inclusion criteria; 2. Patients with other primary malignancies or brain metastases at diagnosis; 3. Patients receiving systemic glucocorticoids (excluding daily glucocorticoid replacement therapy for adrenal or pituitary insufficiency) or other immunosuppressive therapy; 4. Patients with serious endocrine, cardiovascular, hematological, liver and kidney diseases; 5. Pregnant or lactating women and patients with mental disorders.

Design outcomes

Primary

MeasureTime frame
Single cell omics;PFS;ORR;

Secondary

MeasureTime frame
Proteomics;Metabonomics;Intestinal flora;

Countries

China

Contacts

Public ContactChai Kequn

Tongde Hospital of Zhejiang Province

ckq3301@aliyun.com+86 139 0650 3739

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026