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.
Adults aged 18 years or older at the time of study enrollment.
Histologically confirmed gastrointestinal malignancy, including gastric cancer, gastroesophageal junction cancer, esophageal cancer, or colorectal cancer.
Mismatch repair deficiency or microsatellite instability-high (dMMR/MSI-H);
Pathogenic or likely pathogenic POLE or POLD1 mutation;
Uncontrolled progressive metastatic disease or clinical deterioration that precludes evaluation for the study treatment strategy.
Patients who are unable to undergo appropriate clinical, radiological, endoscopic, or pathological assessment required for response evaluation or follow-up.
Previous treatment history or concurrent medical conditions that, in the judgment of the multidisciplinary team, preclude reliable assessment of tumor response or implementation of the predefined surveillance strategy.
Severe comorbidities or medical conditions that make continued follow-up or additional treatment evaluation clinically inappropriate.
The study population will consist of adult patients with histologically confirmed gastrointestinal cancers who are treated at Peking University Cancer Hospital and who have at least one actionable molecular biomarker relevant to immune checkpoint inhibitor therapy, targeted therapy, or other precision treatment strategies. Eligible participants will be identified from the institutional gastrointestinal oncology clinical practice and research database and enrolled into retrospective or prospective cohorts according to the availability of eligible clinical data and the timing of study enrollment.
Cohort
Other
Not listed
3-Year Organ Preservation Success Rate Without Radical Surgery
The proportion of participants who remain free from radical surgical resection and maintain the originally targeted organ at 3 years after initiation of the non-operative management or organ-preservation strategy. Organ preservation success will be assessed using clinical records, imaging, endoscopic evaluation, pathological evaluation when applicable, and subsequent treatment records. Measure: Percentage of participants Unit of Measure: Percentage
3-Year Disease-Free Survival as Determined by Clinical, Radiological, Endoscopic, and Pathological Evidence of Disease Recurrence
Disease-free survival is defined as the time from initiation of the non-operative management or organ-preservation strategy, or from radical surgery for participants in the radical surgery cohort, to the first documented local regrowth, local recurrence, regional recurrence, distant metastasis, second primary gastrointestinal malignancy, or death from any cause. Participants without an event at the date of last follow-up will be censored at that date. Measure: Time to event. Unit of Measure: Months.
3-Year Overall Survival as Determined by All-Cause Mortality
Overall survival is defined as the time from initiation of the non-operative management or organ-preservation strategy, or from radical surgery for participants in the radical surgery cohort, to death from any cause. Participants who are alive at the date of last follow-up will be censored at that date. Measure: Time to event. Events: Months.
3-Year Local Regrowth Rate Determined by Imaging, Endoscopy, and Pathological Evaluation
Local regrowth is defined as the reappearance of viable tumor at or adjacent to the primary tumor site after an initial clinical complete response or near-complete response during the non-operative management or organ-preservation surveillance period. Local regrowth will be assessed by magnetic resonance imaging, computed tomography, endoscopy, biopsy, or other clinically indicated diagnostic procedures. Measure: Percentage of participants. Unit of Measure: Percentage.
3-Year Salvage Radical Surgery Rate After Initial Non-Operative Management
The proportion of participants initially managed with non-operative management or an organ-preservation strategy who subsequently undergo radical surgery because of local regrowth, persistent residual disease, disease progression, inability to achieve or maintain clinical complete response, or other predefined criteria for treatment failure. Measure: Percentage of participants. Unit of Measure: Percentage.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
