Multicenter Retrospective Study on Optimizing Combination Immunotherapy Strategies in MSS/MSI-L/pMMR Advanced Colorectal Cancer
NCT ID: NCT06849362
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
200 participants
OBSERVATIONAL
2019-12-01
2025-05-30
Brief Summary
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Detailed Description
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Study Objectives:
1. To assess clinical outcomes (e.g., overall survival, progression-free survival, objective response rate) in patients receiving different immunotherapy combinations.
2. To evaluate predictive biomarkers that may influence treatment response in MSS/MSI-L/pMMR CRC.
3. To compare the efficacy of various immunotherapy-based regimens, including ICIs combined with chemotherapy, targeted therapy, or anti-angiogenic agents like bevacizumab.
Methods:
* Data Source: Patient records from multiple institutions will be retrospectively analyzed.
* Patient Population: Individuals diagnosed with MSS/MSI-L/pMMR advanced CRC who have received at least one line of immunotherapy-based combination treatment.
* Data Collection: Demographics, tumor characteristics, treatment regimens, survival outcomes, and biomarker profiles.
* Statistical Analysis: Kaplan-Meier survival analysis, Cox proportional hazards model, and subgroup analyses based on biomarker expression.
Eligibility Criteria:
Approval was obtained from the institutional review boards of all four centers, adhering to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines and reported in accordance with the STROCSS 2024 criteria. Informed consent was not required.
* Inclusion Criteria:
* Patients with MSS metastatic colorectal cancer who underwent immunotherapy.
* Comprehensive collection of demographic and molecular characteristics.
* Patients were included irrespective of treatment context.
* Exclusion Criteria:
* Individuals lacking definitive pathological diagnosis.
* Patients without response evaluation data.
* Cases missing pertinent follow-up information.
Treatment Response Evaluation:
Treatment responses were evaluated radiographically according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 guidelines.
Ethical Considerations:
Ethical approval was obtained from the institutional ethics committee of our hospital, ensuring compliance with ethical and regulatory standards for retrospective studies.
Expected Outcomes:
The study aims to identify effective treatment strategies for MSS/MSI-L/pMMR CRC patients, provide real-world evidence on the role of combination immunotherapy, and explore potential predictive biomarkers to improve patient selection for immunotherapy-based approaches.
This research will contribute to optimizing treatment strategies for immunotherapy-resistant CRC subtypes and guide future clinical trials.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Immunotherapy + Bevacizumab Group
Immunotherapy + Bevacizumab Group
Bevacizumab
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 only Group
Immunotherapy only
No interventions assigned to this group
Immunotherapy + Chemotherapy + Bevacizumab Group
Immunotherapy + Chemotherapy + Bevacizumab
Bevacizumab
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.
Chemotherapy only Group
Chemotherapy only
No interventions assigned to this group
Interventions
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Bevacizumab
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.
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Yue Gou
OTHER
Responsible Party
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Yue Gou
MD
Locations
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Xiangya hospital, CSU
Changsha, Hunan, China
Countries
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Other Identifiers
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20240306-MSS-Gou
Identifier Type: -
Identifier Source: org_study_id
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