Gastrointestinal CancersNOR-MPNCT07642323
Safety and Efficacy of NOM and OPFS Versus RO for dMMR/MSI-H or POLE-Mutated Gastrointestinal Cancers
An observational study of Gastrointestinal Cancers and Gastrointestinal Cancers - Stomach, run by Peking University Cancer Hospital & Institute.
Trial summary
Purpose: The purpose of this study is to evaluate the safety and efficacy of Non-Operative Management (NOM) and Organ Preservation First Strategy (OPFS) compared with Radical Operation (RO) in patients with deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancers, Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal
- What is being tested?
- NOM/OPFS
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 15 Jan 2030
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population consists of adult patients diagnosed with primary gastrointestinal cancers (including but not limited to colorectal cancer, gastric cancer, and gastroesophageal junction cancer) that are histologically confirmed as deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or harboring polymerase epsilon (POLE) exonuclease domain mutations. All enrolled patients must have received or are scheduled to receive neoadjuvant or conversion immunotherapy prior to definitive local tumor management strategy determination.
Who may be able to join
- Histologically confirmed primary gastrointestinal adenocarcinoma or squamous cell carcinoma (e.g., colorectal cancer, gastric cancer, gastroesophageal junction cancer).
- Confirmed as deficient mismatch repair (dMMR) by immunohistochemistry (IHC), high microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next-generation sequencing (NGS), or harboring POLE exonuclease domain mutations.
- Received neoadjuvant/conversion immunotherapy (immune checkpoint inhibitors, either monotherapy or combination therapy) prior to treatment response evaluation.
- For the Retrospective Cohort (Part 1): Patients treated between [Start Month/Year] and [End Month/Year] who completed evaluation and subsequent strategy (NOM/OPFS or RO).
- For the Prospective Cohort (Part 2): Newly diagnosed patients who consent to long-term follow-up and multi-disciplinary team (MDT) assessment for organ preservation or radical surgery.
- Age ≥ 18 years at the time of diagnosis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- Concurrently diagnosed with other active malignant tumors within the past 5 years.
- Patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) tumors, or wild-type POLE status.
- Evidence of untreatable distant metastasis or systemic disease that precludes local tumor management (NOM/OPFS or radical operation).
- Inability to undergo regular endoscopic, radiological (MRI/CT), or clinical follow-up due to compliance or geographic reasons.
- Refusal to sign the informed consent form (applicable to the prospective cohort).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Nonoperative Management (NOM) and Organ Preservation First Strategy (OPFS) Versus Radical Operation (RO) for dMMR/MSI-H or POLE-Mutated Gastrointestinal Cancers: A Single-Center, Bidirectional Registry Study
Purpose:
The purpose of this study is to evaluate the safety and efficacy of Non-Operative Management (NOM) and Organ Preservation First Strategy (OPFS) compared with Radical Operation (RO) in patients with deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal cancers.
Read more
Background \& Design:
With the remarkable efficacy of neoadjuvant immunotherapy in dMMR/MSI-H or POLE-mutated gastrointestinal tumors, organ preservation has become a promising alternative to highly invasive surgeries. The NOR-MP trial is a single-center, bidirectional registry study consisting of two parts: a retrospective cohort study and a prospective observational registry.
Intervention Group (NOM/OPFS): Patients who achieve a clinical complete response (cCR) or near-cCR after neoadjuvant immunotherapy will undergo a "Watch \& Wait" (W\&W) strategy. Patients with near-cCR or non-cCR who are eligible for organ preservation will undergo local excision (LE) or endoscopic resection (including ESD or EMR).
Comparison Group (Radical Operation): Patients who undergo standard radical surgical resection after neoadjuvant immunotherapy.
The study aims to determine whether an organ-preserving approach can achieve comparable oncological outcomes and safety profiles while significantly improving patients' quality of life compared to radical surgery.
Read the detailed description
The NOR-MP trial is a single-center, bidirectional registry study designed to compare the clinical outcomes of Organ Preservation First Strategy (OPFS) / Non-Operative Management (NOM) against standard Radical Operation (RO) for patients diagnosed with dMMR/MSI-H or POLE-mutated gastrointestinal cancers. The study is divided into two sequential parts based on the nature of data collection:
Part 1: Retrospective Cohort Study
This part retrospectively reviews the medical records of eligible patients with dMMR/MSI-H or POLE-mutated gastrointestinal cancers who previously completed neoadjuvant immunotherapy. Patients are allocated into two historical cohorts:
Experimental Cohort (NOM/OPFS): Patients who achieved cCR/near-cCR after neoadjuvant immunotherapy and entered the "Watch \& Wait" (W\&W) program, as well as those with near-cCR or non-cCR who underwent local excision (LE) or endoscopic resection (including Endoscopic Submucosal Dissection [ESD] or Endoscopic Mucosal Resection [EMR]).
Control Cohort (RO): Patients who underwent radical surgical operation after neoadjuvant immunotherapy. Pathological outcomes (including the proportions of ypCR, ypTisN0, and ypT1-2N0) and surgical safety data will be collected and analyzed.
Part 2: Prospective Registry Study
This part prospectively enrolls newly diagnosed patients with dMMR/MSI-H or POLE-mutated gastrointestinal cancers receiving neoadjuvant immunotherapy. Following treatment evaluation by the multi-disciplinary NOR-MP research team, patients are enrolled into two parallel observational tracks:
Experimental Cohort (NOM/OPFS): Patients eligible for and consenting to NOM or OPFS. This includes the W\&W strategy for those achieving cCR/near-cCR, and LE or endoscopic resection (ESD/EMR) for those with near-cCR or non-cCR.
Control Cohort (RO): Patients who proceed to standard radical operation. Pathological response distribution (proportions of ypCR, ypTisN0, ypT1-2N0, and ypT3+ diseases) and short-to-long-term surgical safety endpoints will be prospectively documented.
By comparing the retrospective and prospective cohorts, this study evaluates whether the omission of radical surgery is oncologically safe and preserves organ function without compromising long-term survival.
- Conditions
- Gastrointestinal Cancers, Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal, Gastrointestinal Cancers - Anus
- Being tested
- NOM/OPFS
- Keywords
- Gastrointestinal cancers, Colorectal cancer, Gastric cancer
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOM/OPFSOther
Patients eligible for and consenting to NOM or OPFS. This includes the W\&W strategy for those achieving cCR/near-cCR, and LE or endoscopic resection (ESD/EMR) for those with near-cCR or non-cCR.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cohort (NOM/OPFS) | Retrospective Cohort Study: Patients who achieved cCR/near-cCR after neoadjuvant immunotherapy and entered the "Watch \& Wait" (W\&W) program, as well as those with near-cCR or non-cCR who underwent local excision (LE) or endoscopic resection (including Endoscopic Submucosal Dissection [ESD] or Endoscopic Mucosal Resection [EMR]).
Prospective Registry Study: Patients eligible for and consenting to NOM or OPFS. This includes the W\&W strategy for those achieving cCR/near-cCR, and LE or endoscopic resection (ESD/EMR) for those with near-cCR or non-cCR. Receives: Other: NOM/OPFS | |
| Control Cohort (RO) | Retrospective Cohort Study: Patients who underwent radical surgical operation after neoadjuvant immunotherapy. Pathological outcomes (including the proportions of ypCR, ypTisN0, and ypT1-2N0) and surgical safety data will be collected and analyzed. Prospective Registry Study: Patients who proceed to standard radical operation. Pathological response distribution (proportions of ypCR, ypTisN0, ypT1-2N0, and ypT3+ diseases) and short-to-long-term surgical safety endpoints will be prospectively documented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ Preservation Rate (for OPFS/NOM group)
The percentage of patients in the NOM/OPFS group who successfully maintain their native organ without requiring radical surgical resection or permanent stoma.
Measured: Up to 3 years after the completion of neoadjuvant immunotherapy.
Secondary outcomes (5)
Surgical Safety and Postoperative Complications
Incidence and severity of perioperative complications classified by the Clavien-Dindo classification. This compares the safety data among patients undergoing Radical Operation (RO), Local Excision (LE), or endoscopic resection (ESD/EMR).
Measured: Within 30 days and 90 days post-surgery.
Pathological Response Distribution (for RO group)
Proportions of patients in the radical operation cohort achieving pathological complete response (ypCR), ypTisN0, ypT1-2N0, and ypT3+ diseases to characterize the pathological efficacy of neoadjuvant immunotherapy.
Measured: At the time of radical surgery (typically within 4-12 weeks post-immunotherapy).
Local Regrowth / Recurrence Rate
Rate of tumor regrowth in patients undergoing the "Watch \& Wait" strategy, or local recurrence in patients undergoing local/endoscopic excision.
Measured: Followed up at regular intervals (every 3-6 months) up to 3 years.
Overall Survival (OS)
Defined as the time from treatment initiation to death from any cause.
Measured: Up to 5 years.
Disease-Free Survival (DFS) / Disease-Specific Survival (DSS)
To compare the long-term oncological efficacy between the NOM/OPFS group and the RO group. DFS is defined as the time from the start of neoadjuvant immunotherapy to the date of first documentation of disease recurrence (local, regional, or distant), progression, or death from any cause.
Measured: From enrollment/treatment initiation up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancersStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Other
- Enrolment
- 22 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaokang Lei, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642323
- Sponsor's protocol ID
- PKUCH-NORMP trial
- Acronym
- NOR-MP
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Nonoperative Management (NOM) and Organ Preservation First Strategy (OPFS) Versus Radical Operation (RO) for dMMR/MSI-H or POLE-Mutated Gastrointestinal Cancers: A Single-Center, Bidirectional Registry Study
- ClinicalTrials.gov ID
- NCT07642323
- Acronym / sponsor ID
- NOR-MP / PKUCH-NORMP trial
- Conditions
- Gastrointestinal Cancers, Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal, Gastrointestinal Cancers - Anus
- Keywords
- Gastrointestinal cancers, Colorectal cancer, Gastric cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 11 Jun 2026 (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.
Purpose:
The purpose of this study is to evaluate the safety and efficacy of Non-Operative Management (NOM) and Organ Preservation First Strategy (OPFS) compared with Radical Operation (RO) in patients with deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal cancers.
Background \& Design:
With the remarkable efficacy of neoadjuvant immunotherapy in dMMR/MSI-H or POLE-mutated gastrointestinal tumors, organ preservation has become a promising alternative to highly invasive surgeries. The NOR-MP trial is a single-center, bidirectional registry study consisting of two parts: a retrospective cohort study and a prospective observational registry.
Intervention Group (NOM/OPFS): Patients who achieve a clinical complete response (cCR) or near-cCR after neoadjuvant immunotherapy will undergo a "Watch \& Wait" (W\&W) strategy. Patients with near-cCR or non-cCR who are eligible for organ preservation will undergo local excision (LE) or endoscopic resection (including ESD or EMR).
Comparison Group (Radical Operation): Patients who undergo standard radical surgical resection after neoadjuvant immunotherapy.
The study aims to determine whether an organ-preserving approach can achieve comparable oncological outcomes and safety profiles while significantly improving patients' quality of life compared to radical surgery.
Detailed description
The NOR-MP trial is a single-center, bidirectional registry study designed to compare the clinical outcomes of Organ Preservation First Strategy (OPFS) / Non-Operative Management (NOM) against standard Radical Operation (RO) for patients diagnosed with dMMR/MSI-H or POLE-mutated gastrointestinal cancers. The study is divided into two sequential parts based on the nature of data collection:
Part 1: Retrospective Cohort Study
This part retrospectively reviews the medical records of eligible patients with dMMR/MSI-H or POLE-mutated gastrointestinal cancers who previously completed neoadjuvant immunotherapy. Patients are allocated into two historical cohorts:
Experimental Cohort (NOM/OPFS): Patients who achieved cCR/near-cCR after neoadjuvant immunotherapy and entered the "Watch \& Wait" (W\&W) program, as well as those with near-cCR or non-cCR who underwent local excision (LE) or endoscopic resection (including Endoscopic Submucosal Dissection [ESD] or Endoscopic Mucosal Resection [EMR]).
Control Cohort (RO): Patients who underwent radical surgical operation after neoadjuvant immunotherapy. Pathological outcomes (including the proportions of ypCR, ypTisN0, and ypT1-2N0) and surgical safety data will be collected and analyzed.
Part 2: Prospective Registry Study
This part prospectively enrolls newly diagnosed patients with dMMR/MSI-H or POLE-mutated gastrointestinal cancers receiving neoadjuvant immunotherapy. Following treatment evaluation by the multi-disciplinary NOR-MP research team, patients are enrolled into two parallel observational tracks:
Experimental Cohort (NOM/OPFS): Patients eligible for and consenting to NOM or OPFS. This includes the W\&W strategy for those achieving cCR/near-cCR, and LE or endoscopic resection (ESD/EMR) for those with near-cCR or non-cCR.
Control Cohort (RO): Patients who proceed to standard radical operation. Pathological response distribution (proportions of ypCR, ypTisN0, ypT1-2N0, and ypT3+ diseases) and short-to-long-term surgical safety endpoints will be prospectively documented.
By comparing the retrospective and prospective cohorts, this study evaluates whether the omission of radical surgery is oncologically safe and preserves organ function without compromising long-term survival.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Cohort (NOM/OPFS) | – | Other: NOM/OPFSRetrospective Cohort Study: Patients who achieved cCR/near-cCR after neoadjuvant immunotherapy and entered the "Watch \& Wait" (W\&W) program, as well as those with near-cCR or non-cCR who underwent local excision (LE) or endoscopic resection (including Endoscopic Submucosal Dissection [ESD] or Endoscopic Mucosal Resection [EMR]). Prospective Registry Study: Patients eligible for and consenting to NOM or OPFS. This includes the W\&W strategy for those achieving cCR/near-cCR, and LE or endoscopic resection (ESD/EMR) for those with near-cCR or non-cCR. |
| Control Cohort (RO) | – | –Retrospective Cohort Study: Patients who underwent radical surgical operation after neoadjuvant immunotherapy. Pathological outcomes (including the proportions of ypCR, ypTisN0, and ypT1-2N0) and surgical safety data will be collected and analyzed. Prospective Registry Study: Patients who proceed to standard radical operation. Pathological response distribution (proportions of ypCR, ypTisN0, ypT1-2N0, and ypT3+ diseases) and short-to-long-term surgical safety endpoints will be prospectively documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of adult patients diagnosed with primary gastrointestinal cancers (including but not limited to colorectal cancer, gastric cancer, and gastroesophageal junction cancer) that are histologically confirmed as deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or harboring polymerase epsilon (POLE) exonuclease domain mutations. All enrolled patients must have received or are scheduled to receive neoadjuvant or conversion immunotherapy prior to definitive local tumor management strategy determination.
Key inclusion criteria (7 listed)
- Histologically confirmed primary gastrointestinal adenocarcinoma or squamous cell carcinoma (e.g., colorectal cancer, gastric cancer, gastroesophageal junction cancer).
- Confirmed as deficient mismatch repair (dMMR) by immunohistochemistry (IHC), high microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next-generation sequencing (NGS), or harboring POLE exonuclease domain mutations.
- Received neoadjuvant/conversion immunotherapy (immune checkpoint inhibitors, either monotherapy or combination therapy) prior to treatment response evaluation.
- For the Retrospective Cohort (Part 1): Patients treated between [Start Month/Year] and [End Month/Year] who completed evaluation and subsequent strategy (NOM/OPFS or RO).
- For the Prospective Cohort (Part 2): Newly diagnosed patients who consent to long-term follow-up and multi-disciplinary team (MDT) assessment for organ preservation or radical surgery.
Key exclusion criteria (5 listed)
- Concurrently diagnosed with other active malignant tumors within the past 5 years.
- Patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) tumors, or wild-type POLE status.
- Evidence of untreatable distant metastasis or systemic disease that precludes local tumor management (NOM/OPFS or radical operation).
- Inability to undergo regular endoscopic, radiological (MRI/CT), or clinical follow-up due to compliance or geographic reasons.
- Refusal to sign the informed consent form (applicable to the prospective cohort).
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 |
|---|---|---|
| NOM/OPFSPatients eligible for and consenting to NOM or OPFS. This includes the W\&W strategy for those achieving cCR/near-cCR, and LE or endoscopic resection (ESD/EMR) for those with near-cCR or non-cCR. | Other | Experimental Cohort (NOM/OPFS) |
Primary outcome
Organ Preservation Rate (for OPFS/NOM group)
Time frame: Up to 3 years after the completion of neoadjuvant immunotherapy.
The percentage of patients in the NOM/OPFS group who successfully maintain their native organ without requiring radical surgical resection or permanent stoma.
5 secondary outcomes
Surgical Safety and Postoperative Complications
Time frame: Within 30 days and 90 days post-surgery.
Pathological Response Distribution (for RO group)
Time frame: At the time of radical surgery (typically within 4-12 weeks post-immunotherapy).
Local Regrowth / Recurrence Rate
Time frame: Followed up at regular intervals (every 3-6 months) up to 3 years.
Overall Survival (OS)
Time frame: Up to 5 years.
Disease-Free Survival (DFS) / Disease-Specific Survival (DSS)
Time frame: From enrollment/treatment initiation up to 5 years.
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 11 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancers and Gastrointestinal Cancers - Stomach, run by Peking University Cancer Hospital & Institute.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Xiaokang Lei, M.D. (+8618811181993, lxkpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ Preservation Rate (for OPFS/NOM group) (time frame: Up to 3 years after the completion of neoadjuvant immunotherapy.). 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 11 Jun 2026.