Longitudinal analysis of gut microbiome dynamics in patients with tumor immunotherapy

The Study of Gut Microbiota in Patients with Tumor Immunotherapy and Immune-related Adverse Events

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200064816

Enrollment

Unknown

Registered

2022-10-19

Start date

2022-11-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Tumor immunotherapy efficacy and immune-related adverse events

Interventions

Shifting response to tumor immunotherapy group:N/A

No change in the efficacy of tumor immunotherapy group:N/A

Immune-related adverse reaction group:N/A

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. Patients diagnosed with lung cancer and receiving anti-PD-1 immunotherapy; 3. Iraes after receiving anti-PD-1 immunotherapy according to the diagnostic criteria of the national comprehensive cancer network (NCCN); 4. Patients signed an informed consent in writing and volunteered to offer fecal samples in long term.

Exclusion criteria

Exclusion criteria: 1. Vital signs unstable; 2. Patients with Gastrointestinal obstruction, gastrointestinal bleeding, or septic shock; 3. Need long-term antibiotics treatment; 4. Pregnancy and lactation.

Design outcomes

Primary

Measure	Time frame
Fecal microbiome;	—

Countries

China

Contacts

Public ContactTan Bei

Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College

tanbei0626@aliyun.com+86 13601221869

Outcome results

None listed

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