Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07656740

Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Gastrointestinal Cancer Colonic Diseases Colonic Neoplasms Colorectal (Colon or Rectal) Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Stomach (Gastric) Cancer Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Cancer Hospital

Beijing, Haidian District, 100142, China

Location contact

Xiaokang Lei Dr., M.D.

CONTACT

[email protected]

18811181993

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NOM

Other

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).

RO

Other

Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.

Primary outcomes

  1. Organ Preservation Rate

    Time frame: 3 years after the completion of neoadjuvant immunotherapy.

    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).

Secondary outcomes

  1. Surgical Safety and Postoperative Complications

    Time frame: 3 years after the completion of neoadjuvant immunotherapy.

    Incidence and severity of perioperative complications classified by the Clavien-Dindo grading system, comparing RO, LE, and endoscopic resection (ESD/EMR).

  2. Distribution of Pathological Response (RO Group Only)

    Time frame: At the time of radical surgery (typically 4-12 weeks post-immunotherapy).

    Percentage of patients achieving ypCR, ypTisN0, ypT1-2N0, and ypT3+ in the radical surgery cohort to characterize pathological response after immunotherapy.

  3. Local Regrowth Rate

    Time frame: Regular follow-up every 3-6 months for up to 3 years.

    The proportion of patients experiencing local tumor regrowth in the W&W group or after local/endoscopic excision.

  4. Overall Survival (OS)

    Time frame: Up to 5 years.

    Time from the start of treatment to death from any cause.

  5. Disease-Free Survival (DFS)

    Time frame: Up to 5 years from enrollment/treatment initiation.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Wang Prof., M.D.

CONTACT

[email protected]

13910975011

Xiaokang Lei Dr., M.D.

CONTACT

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)

Acronym: NOMIC

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.