An observational study in Gastrointestinal Cancer, Gastric Cancer and Gastroesophageal Junction Cancer, sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Peking University Cancer Hospital & Institute · Observational
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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.
The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and clinical effectiveness of molecular biomarker-guided precision therapy followed by non-operative management (NOM) or organ-preservation strategies in patients with gastrointestinal cancers.
The central hypothesis of the study is that a subset of gastrointestinal cancers with favorable molecular characteristics may achieve a deep and durable tumor response after appropriately selected precision therapy. In carefully selected patients with a complete or near-complete clinical response, a multidisciplinary team (MDT) may identify patients in whom radical surgery can potentially be avoided while maintaining acceptable oncological safety and preserving organ function.
The study is designed to investigate a treatment paradigm in which molecular characteristics are integrated with treatment response and clinical characteristics to support individualized treatment decisions. Molecular biomarkers are therefore considered part of a multidimensional decision-making framework rather than isolated determinants of treatment allocation.
Molecular biomarkers in this study are used primarily to guide the selection of precision therapy rather than to directly determine eligibility for non-operative management. The molecular profile may include immune-related biomarkers, such as mismatch repair deficiency or microsatellite instability-high status, pathogenic POLE or POLD1 alterations, high tumor mutational burden, programmed death ligand 1 combined positive score, and Epstein-Barr virus positivity, as well as biomarkers associated with targeted treatment, such as HER2, CLDN18.2, FGFR2, MET, NTRK, KRAS G12C, and other clinically actionable molecular alterations.
The specific precision therapy received by each participant will be determined according to tumor type, disease stage, molecular characteristics, approved indications, contemporary clinical practice, and the treating multidisciplinary team. Precision therapy may include immune checkpoint inhibitors, targeted therapies, chemotherapy combined with immunotherapy or targeted therapy, or other clinically appropriate systemic treatment approaches.
After precision therapy, treatment response will be evaluated using appropriate clinical, radiological, endoscopic, and pathological assessments according to the primary tumor site. Patients with a favorable response, including clinical complete response or near-complete response, may undergo MDT evaluation for potential non-operative management or organ-preservation treatment.
The MDT decision will consider tumor response, primary tumor location, baseline disease characteristics, molecular profile, treatment history, imaging findings, endoscopic findings, pathological findings when available, patient preferences, expected functional consequences of radical surgery, and the feasibility of intensive surveillance.
Patients considered suitable for non-operative management may undergo a structured watch-and-wait or active surveillance strategy. Selected patients with residual or near-complete response may undergo local treatment, including endoscopic resection or local excision, when clinically appropriate. Patients who do not meet criteria for safe organ preservation, who have persistent or progressive disease, or who require radical treatment based on MDT assessment will undergo radical surgery according to standard clinical practice.
The study includes both a retrospective cohort and a prospective cohort. The retrospective cohort will include eligible patients treated before initiation of prospective enrollment for whom sufficient clinical, molecular, treatment, response, and follow-up data are available. The prospective cohort will include eligible participants enrolled after ethics approval and informed consent, followed according to the predefined study surveillance protocol.
The primary research objective is to evaluate the proportion of patients who achieve successful organ preservation without radical surgery after molecular biomarker-guided precision therapy and MDT-directed NOM or organ-preservation treatment. Secondary objectives include evaluation of disease-free survival, overall survival, local tumor regrowth, salvage radical surgery, permanent stoma, treatment-related morbidity, and patient-reported quality of life and organ function.
The study is observational. Treatment selection, including the choice of precision therapy, NOM, organ-preservation treatment, or radical surgery, will be based on clinical decision-making and will not be assigned randomly by the study.
The presence of an actionable molecular biomarker alone does not constitute an indication for non-operative management. Non-operative management or organ-preservation treatment will only be considered after appropriate precision therapy and comprehensive response assessment, and will require MDT evaluation confirming that the anticipated oncological risk is acceptable and that intensive surveillance is feasible.
696 studies on the registry are indexed under Gastrointestinal Neoplasms; 210 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 168 observational studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Peking University Cancer Hospital & Institute is the lead sponsor of 269 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of at least one molecular biomarker that may support selection of precision therapy, including but not limited to:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Time frame: 3 years after initiation of the non-operative management or organ-preservation strategy
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.
Time frame: 3 years after initiation of the study treatment strategy
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.
Time frame: 3 years after initiation of the study treatment strategy
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.
Time frame: 3 years after initiation of the non-operative management or organ-preservation strategy
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.
Time frame: 3 years after initiation of the non-operative management or organ-preservation strategy
3-Year Permanent Stoma Rate
The proportion of participants who have a permanent intestinal stoma at 3 years after initiation of the non-operative management or organ-preservation strategy or radical surgery, as applicable. Measure: Percentage of participants. Unit of Measure: Percentage.
Time frame: 3 years after initiation of the study treatment strategy
Global Health Status/Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Global health status and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The Global Health Status/Quality of Life scale is transformed to a score ranging from 0 to 100. Higher scores indicate better global health status and quality of life. Measure: Score on a 0 to 100 scale. Unit of Measure: Score.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Physical Functioning Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Physical functioning will be assessed using the Physical Functioning scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score is transformed to a range from 0 to 100. Higher scores indicate better physical functioning. Measure: Score on a 0 to 100 scale. Unit of Measure: Score.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Low Anterior Resection Syndrome Score as Measured by the Low Anterior Resection Syndrome (LARS) Score Questionnaire in Participants With Rectal Cancer
Bowel dysfunction will be assessed using the Low Anterior Resection Syndrome (LARS) Score questionnaire in participants with rectal cancer. The LARS Score ranges from 0 to 42, with higher scores indicating more severe bowel dysfunction. Scores of 0 to 20 indicate no LARS, 21 to 29 indicate minor LARS, and 30 to 42 indicate major LARS. Measure: Score on a 0 to 42 scale. Unit of Measure: Score.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Gastric Cancer-Specific Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Gastric Cancer Module (EORTC QLQ-STO22)
Gastric cancer-specific health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Gastric Cancer Module (EORTC QLQ-STO22). Scores are linearly transformed to a 0 to 100 scale. Higher scores on symptom scales indicate greater symptom burden and worse health-related quality of life. Measure: Score on a 0 to 42 scale. Unit of Measure: Score.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Esophageal Cancer-Specific Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal Cancer Module (EORTC QLQ-OES18)
Esophageal cancer-specific health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal Cancer Module (EORTC QLQ-OES18). Scores are transformed to a 0 to 100 scale. Higher scores on symptom scales indicate greater symptom burden and worse health-related quality of life. Measure: Score on a 0 to 100 scale. Unit of Measure: Score.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
5-Year Overall Survival as Determined by All-Cause Mortality
Overall survival is defined as the time from initiation of the study treatment strategy 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. Unit of Measure: Months.
Time frame: 5 years after initiation of the study treatment strategy
No study locations are listed for this record.
Plan to share: Undecided — Data may be shared upon reasonable request after publication.
Start is estimated for Sep 2026; primary completion for Sep 2030, 48 months later.
Of 79 non-industry observational studies under Gastrointestinal Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 102. This study's planned 48 months is above that.
Counting every sponsor, half of 88 studies reached it within 43 months; a quarter within 16 and three quarters within 102.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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