NOMAD-GI: Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07775859
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and efficacy of molecular biomarker-guided non-operative management (NOM) and organ preservation strategies after precision therapy in patients with gastrointestinal cancers. Patients with actionable molecular biomarkers, including dMMR/MSI-H, POLE mutation, PD-L1 high expression, tumor mutational burden-high (TMB-H), Epstein-Barr virus positivity (EBV+), HER2 positivity, CLDN18.2 positivity, and other actionable genomic alterations, will be enrolled. After immune checkpoint inhibitor or targeted therapy, patients achieving favorable clinical responses will undergo multidisciplinary team (MDT) evaluation and receive either non-operative management, local treatment, or radical surgery according to individualized treatment decisions. The study aims to establish a molecular-driven organ preservation paradigm for gastrointestinal cancers and evaluate whether NOM can provide comparable oncological outcomes while improving functional outcomes and quality of life.

Key Dates

First listed
Aug 20, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Molecular-guided NOM/Organ Preservation Cohort
    Patients receiving molecular-guided precision therapy followed by multidisciplinary evaluation and managed with: * Watch-and-wait strategy; * Endoscopic resection; * Local excision; * Other organ-preserving approaches.
  • Arm: Radical Surgery Cohort
    Patients receiving radical surgical resection after precision therapy. Procedures include: * Radical gastrectomy; * Radical colorectal resection; * Esophagectomy. Participants will not be assigned to a treatment group by the study. The cohort classification will be based on the treatment strategy actually received after precision therapy and MDT evaluation.

Primary Outcome Measure

3-Year Organ Preservation Success Rate Without Radical Surgery [ Time Frame: 3 years after initiation of the non-operative management or organ-preservation strategy ]

Central Contacts

Find similar trials

Nationwide
Colorectal cancer trialsEsophageal cancer trialsGastric cancer trialsOncology trialsGI oncology trials

Related Studies