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Clinical observation of baicalin combined with PD-1 immunotherapy on patients with non-small cell lung cancer

Clinical observation of baicalin combined with PD-1 immunotherapy on patients with non-small cell lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051276
Enrollment
Unknown
Registered
2021-09-17
Start date
2021-09-10
Completion date
Unknown
Last updated
2022-08-08

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

control group:PD-1 inhibitor
experimental group:PD-1 inhibitor plus baicalin combination

Sponsors

Beijing Friendship hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The minimum age of the subjects is 45 and the maximum age is 70; 2. The subject must have histologically or cytologically confirmed non-small cell lung cancer that is not suitable for radical treatment, and is receiving PD-1 immunotherapy; 3. According to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1, subjects must have at least 1 measurable lesion that has not previously received radiotherapy or other locoregional therapy; 4. The subject's Eastern Cooperative Oncology Group (ECOG) status must be 0 or 1; 5. Subjects must sign an ICF (Informed Consent Form) indicating that they understand the purpose and required procedures of the study and are willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. The subject has undergone major surgery within 4 weeks prior to signing the ICF (eg requiring general anesthesia, or not fully recovering from surgery, or planning to undergo surgery during the expected study period); 2. The subjects are known to have heart, brain, kidney and other important organ diseases; 3. The subject is known to suffer from mental illness and unconsciousness; 4. Subjects have received an investigational drug within 3 months prior to randomization or are currently participating in a clinical study.

Design outcomes

Primary

MeasureTime frame
Tumor size;

Secondary

MeasureTime frame
Immune cells and related functional factors;gut microbiota;

Countries

China

Contacts

Public ContactYan Dan

Beijing Friendship Hospital, Capital Medical University

yyd277@126.com+86 13488678873

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026