Colorectal CancerNCT06980350
Proposal of a Novel Model for Identifying Complete Response in dMMR Colon Cancer Following Neoadjuvant Immunotherapy
An observational study of Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
A novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\&W strategy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- PD-1 Inhibitors
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with dMMR colon cancer receiving neoICI therapy
Who may be able to join
- pathologically confirmed colon adenocarcinoma;
- immunohistochemistry testing as dMMR tumors;
- received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting.
- received radical surgery.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
A novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\&W strategy.
Read the detailed description
Immunotherapy shows promise as a curative treatment for patients with non-metastatic dMMR CRC, and offers an option of watch-and-wait (W\&W) strategy for those achieving clinical complete response (cCR). A recent study has tested this hypothesis and demonstrated that 100% of patients (n=42) with localized dMMR rectal cancer achieved cCR after 6 months of neoICI treatment. These patients were managed with a W\&W strategy, and none experienced tumor recurrence over a median follow-up of 26.3 (range 12.4-50.5) months. This result was echoed by our previous studies, in which patients with dMMR rectal cancer who achieved cCR following neoICI demonstrated promising long-term outcomes.
Organ preservation seems promising not only in patients with dMMR rectal cancer, but also in those with dMMR colon cancer who achieve cCR. In the NEOCAP trail, 20 patients with colon cancer were managed with a W\&W strategy, with no tumour regrowth observed over a median follow-up of 11.2 (IQR 5.1-17.7) months. However, the application of organ preservation remains a significant challenge in dMMR colon cancers. This is largely attributed to the fact that tumor responses to neoICI are more prone to be underestimated by radiological assessment. Specifically, patients with pCR were often evaluated as having residual diseases on CT scans. In the PICC trail, 80% (24/30) of patients with partial response (PR) were found to achieve pCR after tumor resection. Similarly, in the NICHE-2 study, only 2 out of 75 patients with pCR had a radiological complete response (CR).5 Hence, a more reliable evaluation model to identify pCR after neoICI in dMMR colon cancer is urgently needed.
In the present study, a novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\&W strategy.
- Conditions
- Colorectal Cancer
- Being tested
- PD-1 Inhibitors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 InhibitorsDrug
Patients received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR)
Complete response: Pathological complete response and clinical complete response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jul 2018
- Primary completion30 Jun 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Rong Ding, Sun Yat-sen University
- Investigators
- Peirong Ding, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980350
- Sponsor's protocol ID
- G2023-176-01
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal of a Novel Model for Identifying Complete Response in dMMR Colon Cancer Following Neoadjuvant Immunotherapy
- ClinicalTrials.gov ID
- NCT06980350
- Acronym / sponsor ID
- G2023-176-01
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 20 May 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.
A novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\&W strategy.
Detailed description
Immunotherapy shows promise as a curative treatment for patients with non-metastatic dMMR CRC, and offers an option of watch-and-wait (W\&W) strategy for those achieving clinical complete response (cCR). A recent study has tested this hypothesis and demonstrated that 100% of patients (n=42) with localized dMMR rectal cancer achieved cCR after 6 months of neoICI treatment. These patients were managed with a W\&W strategy, and none experienced tumor recurrence over a median follow-up of 26.3 (range 12.4-50.5) months. This result was echoed by our previous studies, in which patients with dMMR rectal cancer who achieved cCR following neoICI demonstrated promising long-term outcomes.
Organ preservation seems promising not only in patients with dMMR rectal cancer, but also in those with dMMR colon cancer who achieve cCR. In the NEOCAP trail, 20 patients with colon cancer were managed with a W\&W strategy, with no tumour regrowth observed over a median follow-up of 11.2 (IQR 5.1-17.7) months. However, the application of organ preservation remains a significant challenge in dMMR colon cancers. This is largely attributed to the fact that tumor responses to neoICI are more prone to be underestimated by radiological assessment. Specifically, patients with pCR were often evaluated as having residual diseases on CT scans. In the PICC trail, 80% (24/30) of patients with partial response (PR) were found to achieve pCR after tumor resection. Similarly, in the NICHE-2 study, only 2 out of 75 patients with pCR had a radiological complete response (CR).5 Hence, a more reliable evaluation model to identify pCR after neoICI in dMMR colon cancer is urgently needed.
In the present study, a novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\&W strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with dMMR colon cancer receiving neoICI therapy
Key inclusion criteria (4 listed)
- pathologically confirmed colon adenocarcinoma;
- immunohistochemistry testing as dMMR tumors;
- received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting.
- received radical surgery.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PD-1 InhibitorsPatients received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting. | Drug | – |
Primary outcome
Complete response (CR)
Time frame: 1 year
Complete response: Pathological complete response and clinical complete response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Peirong Ding, M.D. principal investigator
Sun Yat-Sen University Cancer Center
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 Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete response (CR) (time frame: 1 year). 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 29 Jul 2025.