Effect of Gut Microbiota and Its Metabolites on the Efficacy of Immunotherapy in Metastatic Colorectal Cancer

NCT06714903 | Recruiting DMC

• 1 other identifier: 2024-HS-147
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to understand the effect of gut microbiota on the efficacy of immunotherapy in patients with metastatic colorectal cancer and to explore the specific mechanisms of this process. In this way, it provides new ideas for the clinical treatment of colorectal cancer.

Conditions

Colorectal Neoplasms Malignant

Keywords

Metastatic colorectal cancer; Immunotherapy; Gut microbiota; Prognosis; Metabolism

Outcome Measures

Primary Outcomes (1)

• Evaluation of efficacy

  Six months after treatment with a PD-1 inhibitor in combination with fruquintinib, patients with mCRC were evaluated radiographically according to the modified RECIST1.1 criteria for immunotherapy (iRECIST) and were divided into responsive and non-responsive groups. Patients are classified as responders if they achieve an objective response (complete or partial response or stable disease for at least 6 months), while patients are classified as non-responders if they have progressed on treatment or have stable disease for less than 6 months.

  six months after treatment

Study Arms (2)

Experimental group

sintilimab + fruquintinib

Other: treatment option-sintilimab plus fruquintinib

Control group

fruquintinib

Other: treatment option-fruquintinib alone

Interventions

treatment option-sintilimab plus fruquintinib OTHER

sintilimab plus fruquintinib

Experimental group

treatment option-fruquintinib alone OTHER

fruquintinib alone

Control group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 50 patients with metastatic colorectal cancer who received immunotherapy from the First Hospital of Jilin University from 2024 to 2026 were included

You may qualify if:

• Clinical and pathological diagnosis of metastatic colorectal cancer
• years old (both ends inclusive)
• complete clinical information
• signed informed consent

You may not qualify if:

• combined with severe respiratory and circulatory diseases
• combined with other malignant tumors
• recent severe active bleeding, uncontrolled active infection or active peptic ulcer
• moderate to severe renal insufficiency
• other circumstances that are judged by the investigator to be unsuitable for participating in this study

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and stool samples

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nan Zhang

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Nan Zhang

CONTACT

18686440802; zhangnan@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 4, 2024
• Study Start: July 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-08

Locations

CN (1)