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Study on the Relationship Between Immunotherapy Efficacy and Gut Microbiota in Gastrointestinal Malignancies

Association of Gut Microbiota and Related Metabolic Characteristics with Anti-PD-1/PD-L1 Immunotherapy Efficacy in Locally Advanced and Advanced Gastrointestinal Malignancies: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128631
Enrollment
Unknown
Registered
2026-07-23
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Locally advanced or advanced gastric and colorectal cancers

Interventions

Colorectal cancer immunotherapy group:None
Gastric cancer immunotherapy group:None
Colorectal cancer negative control group:None
Gastric cancer negative control group:None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients pathologically diagnosed with locally advanced or advanced gastric cancer or colorectal cancer; 2.Age 18 years or older, regardless of sex; 3.For patients with locally advanced disease: patients who are planned to receive PD-1/PD-L1 monoclonal antibody-based immunotherapy, or neoadjuvant therapy combining immunotherapy with radiotherapy, chemotherapy, or other treatments; 4.For patients with advanced disease: patients who are planned to receive immunotherapy-based monotherapy or combination therapy; 5.For patients in the control group: patients who receive chemotherapy or molecular targeted therapy only, without relevant immunotherapy, and who are considered by the investigator to meet the observational requirements of this study; 6.Expected survival time of more than 3 months; 7.Ability to cooperate with the collection of study-related data, biological samples, and follow-up; 8.Voluntary participation in this study and provision of written informed consent;

Exclusion criteria

Exclusion criteria: 1.Patients with cognitive impairment, or patients with brain metastases who have clinical symptoms that prevent them from completing questionnaire-based communication; 2.Patients with severe infection or severe dysfunction of major organs, including the heart, liver, or kidneys; 3.Patients with active infection, including viral, bacterial, fungal, or other microbial infections, or other conditions that may affect gut microbiota composition in the short term; 4.Patients with diarrhea, gastrointestinal inflammation, except chronic atrophic gastritis or non-atrophic gastritis, or other infectious lesions; 5.Patients who have used antibiotics within the past 1 month; 6.Other conditions that the investigator considers unsuitable for study enrollment;

Design outcomes

Primary

MeasureTime frame
Microbial and metabolic features;Treatment efficacy;Survival and prognostic outcomes;

Secondary

MeasureTime frame
Safety outcomes;

Countries

China

Contacts

Public ContactSun Weijian

The First Affiliated Hospital of Wenzhou Medical University

fame198288@126.com+86 577 1234567

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026