The Study of Effects of Probiotics on Tumor Immunotherapy Efficacy and Immune-related Adverse Events

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300069535

Enrollment

Unknown

Registered

2023-03-20

Start date

2023-04-01

Completion date

Unknown

Last updated

2023-05-29

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

control group :None

probiotic intervention group:probiotics

Eligibility

Sex/Gender

Male

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: A. for patients initially retreated with ICIs 1) >18-year-old, no limitation on genders; 2) diagnosed with lung cancer, initially receiving anti-PD-1 therapy with or without combined chemotherapy; 3) planned to receive = 4 courses of ICIs and = 2 efficacy evaluation; 4) with written informed consent. B. For irAE patients 1) >18-year-old, no limitation on genders; 2) diagnosed with lung cancer, initially receiving anti-PD-1 therapy with or without combined chemotherapy; 3) diagnosed with irAE regardless of involved organs after anti-PD-1 therapy, according to NCCN diagnosis criteria; 4) irAE remission to grade 1 and tapering prednisone to < 10mg/d, with or without resuming anti-PD-1 therapy; 5) with written informed consent.

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: Pregnancy and lactation.

Design outcomes

Primary

Measure	Time frame
ICI efficacy;incidence of irAE occurrence;severity of irAE;	—

Secondary

Measure	Time frame
Fecal microbiome;fecal metabolites;lymphocyte subsets;fecal calprotectin;progression free survival;overall survival;time from initial response to secondary resistance;response rate to irAE glucocorticoid treatment;remission time for irAE glucocorticoid treatment;remission grade for irAE glucocorticoid treatment;recurrence rate of irAE;recurrence grade of irAE;recurrence type of irAE;	—

Countries

China

Contacts

Public ContactTan Bei

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

tanbei0626@aliyun.com+86 10 69155017

Outcome results

None listed

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