Multicenter Retrospective Study on Optimizing Combination Immunotherapy Strategies in MSS/MSI-L/pMMR Advanced Colorectal Cancer

NCT06849362 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: 20240306-MSS-Gou
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter retrospective study aims to evaluate and optimize combination immunotherapy strategies for patients with microsatellite stable (MSS), microsatellite instability-low (MSI-L), or mismatch repair-proficient (pMMR) advanced colorectal cancer (CRC). The study will analyze clinical outcomes, treatment responses, and prognostic factors in patients who received various immunotherapy regimens. Data from multiple institutions will be collected to identify potential predictive biomarkers and effective therapeutic combinations. The findings may provide critical insights for improving immunotherapy strategies in MSS/MSI-L/pMMR CRC patients.

Conditions

Metastatic Colorectal Cancer (CRC); MSS Metastatic Colorectal Cancer; Immunotherapy

Keywords

MSS Colorectal Cancer; MSI-L Colorectal Cancer; pMMR Colorectal Cancer; Combination Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Disease Control Rate

  Disease Control Rate (DCR)

  02/28/2024

• Progression-Free Survival

  Progression-Free Survival (PFS)

  02/28/2024

Secondary Outcomes (2)

• Objective Response Rate

  02/28/2024

• Overall Survival

  02/28/2024

Study Arms (4)

Immunotherapy + Bevacizumab Group

Immunotherapy + Bevacizumab Group

Drug: Bevacizumab

Immunotherapy only Group

Immunotherapy only

Immunotherapy + Chemotherapy + Bevacizumab Group

Immunotherapy + Chemotherapy + Bevacizumab

Drug: Bevacizumab

Chemotherapy only Group

Chemotherapy only

Interventions

Bevacizumab DRUG

Bevacizumab is an anti-vascular endothelial growth factor (VEGF) monoclonal antibody used in combination with chemotherapy or immunotherapy for the treatment of metastatic colorectal cancer (CRC). In this study, bevacizumab is administered as part of combination therapy in certain patient groups to assess its impact on treatment efficacy in MSS/MSI-L/pMMR advanced colorectal cancer. Patients receiving bevacizumab will be evaluated for treatment response, survival outcomes, and potential biomarkers predictive of therapeutic efficacy. The study will compare the clinical benefits of immunotherapy alone, immunotherapy + bevacizumab, and immunotherapy + chemotherapy + bevacizumab to determine the optimal treatment strategy. The dose and administration schedule of bevacizumab will follow standard clinical guidelines as per institutional protocols.

Immunotherapy + Bevacizumab Group; Immunotherapy + Chemotherapy + Bevacizumab Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes patients diagnosed with microsatellite stable (MSS), microsatellite instability-low (MSI-L), or mismatch repair-proficient (pMMR) metastatic colorectal cancer (CRC) who have undergone immunotherapy-based treatment. Eligible participants are those who received immune checkpoint inhibitors (ICIs) alone or in combination with chemotherapy and/or bevacizumab as part of their treatment regimen. Patients were enrolled from multiple medical centers, with data collected retrospectively. Inclusion criteria require a confirmed pathological diagnosis of MSS/MSI-L/pMMR CRC, available treatment and follow-up data, and a history of receiving at least one immunotherapy-based regimen. Exclusion criteria include patients lacking complete clinical records, follow-up data, or radiographic response assessments.

Sponsors & Collaborators

• Yue Gou: lead

Study Sites (1)

Xiangya hospital, CSU

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: December 1, 2019
• Primary Completion: February 28, 2024
• Study Completion: May 30, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CN (1)