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Safety and Efficacy of NOM and OPFS Versus RO for dMMR/MSI-H or POLE-Mutated Gastrointestinal Cancers (NOR-MP)

6 giugno 2026 aggiornato da: Xiaokang Lei, Peking University Cancer Hospital & Institute

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.

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

22

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Xiaokang Lei, M.D.
  • Numero di telefono: +8618811181993
  • Email: lxkpku@163.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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)

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Organ Preservation Rate (for OPFS/NOM group)
Lasso di tempo: 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.
Up to 3 years after the completion of neoadjuvant immunotherapy.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Surgical Safety and Postoperative Complications
Lasso di tempo: Within 30 days and 90 days post-surgery.
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).
Within 30 days and 90 days post-surgery.
Pathological Response Distribution (for RO group)
Lasso di tempo: At the time of radical surgery (typically within 4-12 weeks post-immunotherapy).
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.
At the time of radical surgery (typically within 4-12 weeks post-immunotherapy).
Local Regrowth / Recurrence Rate
Lasso di tempo: Followed up at regular intervals (every 3-6 months) up to 3 years.
Rate of tumor regrowth in patients undergoing the "Watch & Wait" strategy, or local recurrence in patients undergoing local/endoscopic excision.
Followed up at regular intervals (every 3-6 months) up to 3 years.
Overall Survival (OS)
Lasso di tempo: Up to 5 years.
Defined as the time from treatment initiation to death from any cause.
Up to 5 years.
Disease-Free Survival (DFS) / Disease-Specific Survival (DSS)
Lasso di tempo: From enrollment/treatment initiation up to 5 years.
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.
From enrollment/treatment initiation up to 5 years.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University Cancer Hospital & Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 luglio 2026

Completamento primario (Stimato)

15 gennaio 2027

Completamento dello studio (Stimato)

15 gennaio 2030

Date di iscrizione allo studio

Primo inviato

6 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PKUCH-NORMP trial

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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