Metastatic Colorectal Cancer (CRC)NCT06849362
Multicenter Retrospective Study on Optimizing Combination Immunotherapy Strategies in MSS/MSI-L/pMMR Advanced Colorectal Cancer
An observational study of Metastatic Colorectal Cancer (CRC) and MSS Metastatic Colorectal Cancer, run by Yue Gou at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC), MSS Metastatic Colorectal Cancer, Immunotherapy
- What is being tested?
- Bevacizumab
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Inclusion Criteria:1) study subjects were mCRC patients with explicitly stated MSS/MSI-L/pMMR status; 2) at least one cohort included immunotherapy treatment; 3); primary outcomes of this study were defined as Disease Control Rate (DCR) and Progression-Free Survival (PFS); secondary outcomes included Objective Response Rate (ORR), Overall Survival (OS), and Adverse Drug Reactions (ADRs) Exclusion Criteria: individuals lacking definitive pathological diagnosis, response evaluation, or pertinent follow-up data
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Retrospective Study on Optimizing Combination Immunotherapy Strategies for MSS/MSI-L/pMMR Advanced Colorectal Cancer: Comprehensive Clinical and Prognostic Analysis
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.
Read the detailed description
This multicenter retrospective cohort study aims to evaluate the effectiveness of combination immunotherapy strategies in microsatellite stable (MSS), microsatellite instability-low (MSI-L), and mismatch repair-proficient (pMMR) advanced colorectal cancer (CRC) patients. Given the limited response of these CRC subtypes to immune checkpoint inhibitors (ICIs) alone, this study seeks to identify optimal combination regimens that can enhance therapeutic efficacy.
Study Objectives:
- To assess clinical outcomes (e.g., overall survival, progression-free survival, objective response rate) in patients receiving different immunotherapy combinations.
- To evaluate predictive biomarkers that may influence treatment response in MSS/MSI-L/pMMR CRC.
- 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.
- Being tested
- Bevacizumab
- Keywords
- MSS Colorectal Cancer, MSI-L Colorectal Cancer, pMMR Colorectal Cancer, Combination Immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy + Bevacizumab Group | Immunotherapy + Bevacizumab Group Receives: Drug: Bevacizumab | |
| Immunotherapy only Group | Immunotherapy only | |
| Immunotherapy + Chemotherapy + Bevacizumab Group | Immunotherapy + Chemotherapy + Bevacizumab Receives: Drug: Bevacizumab | |
| Chemotherapy only Group | Chemotherapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate
Disease Control Rate (DCR)
Measured: 02/28/2024
Progression-Free Survival
Progression-Free Survival (PFS)
Measured: 02/28/2024
Secondary outcomes (2)
Objective Response Rate
Objective Response Rate (ORR)
Measured: 02/28/2024
Overall Survival
Overall Survival (OS)
Measured: 02/28/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Dec 2019
- Primary completion28 Feb 2024
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yue Gou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yue Gou, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849362
- Sponsor's protocol ID
- 20240306-MSS-Gou
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Since the data collection and analysis for this study are ongoing, the decision on sharing individual participant data (IPD) has not been finalized. Data sharing will be considered in accordance with institutional policies, ethical guidelines, and patient confidentiality regulations. If data sharing is approved in the future, details regarding access and sharing mechanisms will be specified accordingly.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Study on Optimizing Combination Immunotherapy Strategies for MSS/MSI-L/pMMR Advanced Colorectal Cancer: Comprehensive Clinical and Prognostic Analysis
- ClinicalTrials.gov ID
- NCT06849362
- Acronym / sponsor ID
- 20240306-MSS-Gou
- Keywords
- MSS Colorectal Cancer, MSI-L Colorectal Cancer, pMMR Colorectal Cancer, Combination Immunotherapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yue GouUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter retrospective cohort study aims to evaluate the effectiveness of combination immunotherapy strategies in microsatellite stable (MSS), microsatellite instability-low (MSI-L), and mismatch repair-proficient (pMMR) advanced colorectal cancer (CRC) patients. Given the limited response of these CRC subtypes to immune checkpoint inhibitors (ICIs) alone, this study seeks to identify optimal combination regimens that can enhance therapeutic efficacy.
Study Objectives:
- To assess clinical outcomes (e.g., overall survival, progression-free survival, objective response rate) in patients receiving different immunotherapy combinations.
- To evaluate predictive biomarkers that may influence treatment response in MSS/MSI-L/pMMR CRC.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy + Bevacizumab Group | – | Drug: BevacizumabImmunotherapy + Bevacizumab Group |
| Immunotherapy only Group | – | –Immunotherapy only |
| Immunotherapy + Chemotherapy + Bevacizumab Group | – | Drug: BevacizumabImmunotherapy + Chemotherapy + Bevacizumab |
| Chemotherapy only Group | – | –Chemotherapy only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabBevacizumab 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. | Drug | Immunotherapy + Bevacizumab Group, Immunotherapy + Chemotherapy + Bevacizumab Group |
Primary outcome
Disease Control Rate
Time frame: 02/28/2024
Disease Control Rate (DCR)
Progression-Free Survival
Time frame: 02/28/2024
Progression-Free Survival (PFS)
2 secondary outcomes
Objective Response Rate
Time frame: 02/28/2024
Overall Survival
Time frame: 02/28/2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided. Since the data collection and analysis for this study are ongoing, the decision on sharing individual participant data (IPD) has not been finalized. Data sharing will be considered in accordance with institutional policies, ethical guidelines, and patient confidentiality regulations. If data sharing is approved in the future, details regarding access and sharing mechanisms will be specified accordingly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer (CRC) and MSS Metastatic Colorectal Cancer, run by Yue Gou at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (time frame: 02/28/2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.