Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC)
15 juni 2026 uppdaterad av: Xiaokang Lei, Peking University Cancer Hospital & Institute
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)
This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch & Wait" (W&W) strategy, while those with near-cCR or non-cCR ($\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
50
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Lin Wang Prof., M.D.
- Telefonnummer: 13910975011
- E-post: wanglinmd@foxmail.com
Studera Kontakt Backup
- Namn: Xiaokang Lei Dr., M.D.
Studieorter
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Haidian District
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Beijing, Haidian District, Kina, 100142
- Peking University Cancer Hospital
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Kontakt:
- Xiaokang Lei Dr., M.D.
- Telefonnummer: 18811181993
- E-post: lxkpku@163.com
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.
Beskrivning
Inclusion Criteria:
Retrospective Cohort Inclusion Criteria
- Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- Completed prior immunotherapy.
- No evidence of distant metastasis.
- Managed with W&W, LE, endoscopic surgery, or radical operation after treatment.
Prospective Cohort Inclusion Criteria
- Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR/near-cCR or Non-cCR (≤ ymrT2N0).
- No evidence of distant metastasis.
- Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction).
Exclusion Criteria:
- Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.
- Serum creatinine > 1.5 times upper limit of normal (ULN).
- History of pelvic radiation therapy.Inability to tolerate MRI examinations.
- History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).
- Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack [TIA], cerebral vascular accident [CVA]).
- Prior receipt of other types of investigational anti-tumor therapies.
- Pregnant or lactating women.
- Concomitant diseases or mental health conditions that may interfere with study participation.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Experimental Cohort (NOM)
Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch & Wait" (W&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
|
Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch & Wait" (W&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
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Control arm
Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
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Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Organ Preservation Rate
Tidsram: 3 years after the completion of neoadjuvant immunotherapy.
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The proportion of patients successfully managed with NOM without the need for supplementary radical surgery, loss of organ function, or a permanent stoma (specifically for rectal cancer patients).
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3 years after the completion of neoadjuvant immunotherapy.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Övergripande överlevnad (OS)
Tidsram: Upp till 5 år.
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Tid från början av behandlingen till döden från någon orsak.
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Upp till 5 år.
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Surgical Safety and Postoperative Complications
Tidsram: 3 years after the completion of neoadjuvant immunotherapy.
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Incidence and severity of perioperative complications classified by the Clavien-Dindo grading system, comparing RO, LE, and endoscopic resection (ESD/EMR).
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3 years after the completion of neoadjuvant immunotherapy.
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Distribution of Pathological Response (RO Group Only)
Tidsram: At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
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Percentage of patients achieving ypCR, ypTisN0, ypT1-2N0, and ypT3+ in the radical surgery cohort to characterize pathological response after immunotherapy.
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At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
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Local Regrowth Rate
Tidsram: Regular follow-up every 3-6 months for up to 3 years.
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The proportion of patients experiencing local tumor regrowth in the W&W group or after local/endoscopic excision.
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Regular follow-up every 3-6 months for up to 3 years.
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Disease-Free Survival (DFS)
Tidsram: Up to 5 years from enrollment/treatment initiation.
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Time from the initiation of neoadjuvant immunotherapy to the first documentation of disease recurrence (local, regional, or distant), progression, or death from any cause, comparing the NOM/OPFS group with the RO group.
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Up to 5 years from enrollment/treatment initiation.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 juni 2026
Primärt slutförande (Beräknad)
15 juni 2029
Avslutad studie (Beräknad)
15 oktober 2030
Studieregistreringsdatum
Först inskickad
15 juni 2026
Först inskickad som uppfyllde QC-kriterierna
15 juni 2026
Första postat (Faktisk)
18 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NOMIC Trial
Plan för individuella deltagardata (IPD)
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NEJ
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Nej
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