Fecal Microbiota Transplantation for Tumor Immunotherapy Resistance and Refractory Immune-related Adverse Events

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066475

Enrollment

Unknown

Registered

2022-12-06

Start date

2022-12-15

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

Patients with primary resistance to ICI:fecal microbiota transplantation

Patients with secondary resistance to ICI:fecal microbiota transplantation

Patients with irAE related colitis:fecal microbiota transplantation

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Aged >=18 years, regardless of gender 2: Patients diagnosed with non-small cell lung cancer and receiving anti-PD-1 immunotherapy 3: ICI effectiveness assessment after 2 courses of treatment: primary resistance or secondary resistance 4: Refractory irAE

Exclusion criteria

Exclusion criteria: 1: Vital signs unstable 2: Patients with gastrointestinal obstruction, gastrointestinal bleeding, or infectious colitis 3: Usage of antibiotics or probiotics 4: intolerance to or failure in colonoscope examination 5: Patient confirmed with colitis before anti-PD-1 treatment 6: Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Fecal microbiome;fecal metabolome;	—

Countries

China

Contacts

Public ContactTan Bei

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

tanbei0626@aliyun.com+86 010 69155017

Outcome results

None listed

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