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Prospective study of Shenlingbaizhu Powder in the treatment of advanced non-small cell lung cancer with PD-1 inhibitor

Prospective study of Shenlingbaizhu Powder in the treatment of advanced non-small cell lung cancer with PD-1 inhibitor

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061279
Enrollment
Unknown
Registered
2022-06-19
Start date
2022-06-05
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

non-small cell lung cancer

Interventions

Group 1 :
Group 2:

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, gender is not limited; 2. Non-small cell lung cancer diagnosed by pathology (tissue or cytology) (according to the 2015 version of the World Health Organization's histological classification of lung cancer); 3. Subjects with stage IIIB-IV NSCLC confirmed by histology or cytology according to the 8th edition of the TNM staging of lung cancer of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (attached documents); 4. The expected survival period is 3 months or more; 5. ECOG score: <= 2 points; 6. The investigator has at least one measurable lesion according to the efficacy evaluation of RECIST 1.1 standard; 7. Those who voluntarily participate in this research can follow up as required and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with any other primary malignant tumors; 2. Pregnant or lactating women; 3. Patients who are fertile but unwilling or unable to take effective contraceptive measures; 4. Patients with drug abuse and medical, psychological or social conditions that may interfere with participation in the research or have an impact on the research results; 5. Patients without current address and fixed contact information.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective response rate;Disease control rate;Fact-L4.0 scale score;Lung cancer Chinese medicine symptom scale score;Expression levels of peripheral blood T lymphocyte subsets (CD4+T cells, CD8+T cells, CD4+/CD8+T cells, NK cells);

Countries

China

Contacts

Public ContactCuiling Feng

Peking University People's Hospital

fengcuiling@sina.com+86 15901341502

Outcome results

None listed

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