Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer

N/ANot Yet RecruitingNCT06375434

Jing-kun Liu100 enrolled

Overview

The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy.

The study is expected to enroll 100 patients with locally advanced rectal cancer, including 50 patients in the radiotherapy-sensitive group and 50 in the radiotherapy-resistant group. Each participant will provide stool and blood samples before treatment for subsequent metagenomic and metabolomic sequencing analysis.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Locally Advanced Rectal Cancer

Interventions

No interventionOTHER

No intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with late-stage rectal cancer (stages IIIB to IV), including those with postoperative recurrence re-staging or those intending to receive neoadjuvant treatment, 2. Pathological type is adenocarcinoma, 3. Have measurable lesions before radiotherapy or chemotherapy, 4. Age between 18 and 75 years, 5. A WHO Performance Status (PS) score of 0 to 2, capable of tolerating radiotherapy or chemotherapy, 6. An expected survival period of 6 months or more; 7. Able to understand the study and sign the informed consent form. Exclusion Criteria: 1. Patients with severe complications or other malignant diseases. 2. Known severe allergic reactions to components of radiotherapy or chemotherapy. 3. Significant cardiac, hepatic, renal, or other vital organ dysfunction. 4. Pregnant or breastfeeding women. 5. Patients unable to comply with study requirements or affected by psychiatric or psychological diseases. 6. Participation in other clinical trials recently that could affect the assessment of this study's results.

Outcomes

Primary Outcomes

Diameter of tumor

The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated

Time frame: 30 days

Secondary Outcomes

Change in Gut Microbiota Composition

Change in gut microbiota composition, including alterations in bacterial taxa, diversity, and abundance, between rectal cancer patients sensitive to radiotherapy and a control group of patients insensitive to radiotherapy.

Time frame: 30 days

Change in Plasma metabolites

Metabolomics sequencing, including profiling of metabolites and their differences, was performed on patients' plasma before radiotherapy.

Time frame: 30 days

Data from ClinicalTrials.gov

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