Gastric AdenocarcinomaNA-LND-GCNCT07902596
Lymph Node Dissection After Neoadjuvant Therapy for Gastric and EGJ Adenocarcinoma
An observational study of Gastric Adenocarcinoma and Esophagogastric Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 8 sites in China.
Trial summary
This multicenter retrospective observational cohort study will evaluate approximately 2,000 adults with gastric or esophagogastric junction adenocarcinoma who received at least two cycles of neoadjuvant therapy followed by R0 gastrectomy with lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma
- How many people
- 2,000 participants
- Where
- 8 sitesChina
- Study dates
- 25 Oct 2026to 27 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults treated at participating tertiary hospitals in China who underwent surgery from January 1, 2021, through August 30, 2026, for histologically confirmed gastric or esophagogastric junction adenocarcinoma after neoadjuvant therapy.
Who may be able to join
- Age 18 years or older.
- Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma.
- Completion of at least two cycles of neoadjuvant chemotherapy, chemotherapy combined with immunotherapy, or chemoradiotherapy.
- Final preoperative imaging assessment within four weeks before surgery with evaluable ycT and ycN categories according to the AJCC/UICC eighth edition.
- ycM0 disease before surgery.
- R0 curative-intent total, distal, or proximal gastrectomy with lymph node dissection.
- Identifiable surgical procedure and evaluable station-specific lymph node pathological records.
- Surgery performed between January 1, 2021, and August 30, 2026.
Who cannot join
- Histological diagnosis other than adenocarcinoma, including squamous cell carcinoma, lymphoma, gastrointestinal stromal tumor, or neuroendocrine neoplasm.
- Conversion therapy for initially unresectable or metastatic disease.
- Intraperitoneal hyperthermic perfusion treatment.
- ycM1 disease, including peritoneal, hepatic, or other distant metastasis.
- R1 or R2 resection, palliative surgery, or exploratory surgery without curative gastrectomy.
- Previous gastrectomy.
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- Synchronous multiple primary gastric cancers.
- Another active malignant tumor.
- Missing core data required for eligibility or the primary analysis, including ycT, ycN, gastrectomy type, or station-specific pathological records.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu
Jiangsu Cancer Hospital
Nanjing, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
About this study
Official title: Optimizing the Extent of Lymph Node Dissection After Neoadjuvant Therapy for Gastric and Esophagogastric Junction Adenocarcinoma: A Multicenter Retrospective Cohort Study
This multicenter retrospective observational cohort study will evaluate approximately 2,000 adults with gastric or esophagogastric junction adenocarcinoma who received at least two cycles of neoadjuvant therapy followed by R0 gastrectomy with lymph node dissection. The study will estimate the frequency of pathological metastasis at individual lymph node stations according to the final preoperative imaging-based ycT and ycN categories and tumor location. The findings are intended to provide evidence for future prospective studies of risk-adapted reduction of perigastric lymph node dissection. No treatment is assigned by this study.
Read the detailed description
This study will retrospectively collect de-identified clinical, imaging, operative, and pathological data from participating centers. Eligible operations will have been performed from January 1, 2021, through August 30, 2026. Neoadjuvant regimens may include chemotherapy, chemotherapy combined with immunotherapy, or chemoradiotherapy; patients treated with conversion therapy or intraperitoneal hyperthermic perfusion will not be included.
The last preoperative staging assessment must be completed within four weeks before surgery. The routine ycT and ycN categories will be determined by each center's multidisciplinary team, primarily using contrast-enhanced computed tomography and supplemented by endoscopy, endoscopic ultrasonography, or positron emission tomography-computed tomography when clinically indicated. De-identified final preoperative imaging will undergo independent blinded central review by two experienced gastric cancer radiologists, with discrepancies resolved by consensus. The central review ycT and ycN categories will be used for the primary analysis, and local multidisciplinary staging will be examined in sensitivity analyses. Staging will follow the eighth edition of the AJCC/UICC system. Only patients with ycM0 disease will be eligible.
Tumors will be classified into four mutually exclusive location cohorts. The E cohort includes tumors whose upper margin reaches or crosses the esophagogastric junction, or for which endoscopy explicitly reports an unclear, immediately adjacent, or involved dentate line. Other gastric tumors will be classified as U, M, or L according to the upper, middle, or lower third of the stomach under the Japanese Gastric Cancer Association anatomical system; tumors spanning more than one region will be assigned according to the location of the tumor center.
Station-specific pathological data will include No. 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 10, 11p, 11d, and 12a lymph nodes, with other para-aortic, abdominal, or mediastinal stations recorded separately. For each station, the denominator will include only patients in whom that station was actually dissected and had an evaluable station-specific pathological record. A station that was not dissected or could not be confirmed will be excluded from that station's denominator and will not be assumed to be pathologically negative.
Data will be entered into a standardized case report form, de-identified locally, and transferred to the coordinating center for centralized quality control and analysis. Additional participating centers may be added after registration. Station-specific metastasis proportions will be reported with Clopper-Pearson exact 95% confidence intervals. Group comparisons will use chi-square or Fisher exact tests as appropriate. Multilevel analyses will account for center effects, and exploratory comparisons across multiple nodal stations will use the Benjamini-Hochberg false discovery rate procedure. Firth penalized regression or exact estimates will be used for sparse outcomes; conventional multivariable models will be limited to outcomes with adequate event counts.
- Keywords
- Neoadjuvant Therapy, Lymph Node Metastasis, Lymph Node Dissection, Gastric Cancer, Esophagogastric Junction Cancer, Preoperative Staging, Multicenter Retrospective Cohort
- Medical subject headings
- Lymphatic Metastasis, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| E cohort | Patients with tumors whose upper margin reaches or crosses the esophagogastric junction, or whose endoscopy report explicitly describes an unclear, immediately adjacent, or involved dentate line. | |
| U cohort | Patients with non-E tumors centered in the upper third of the stomach according to the Japanese Gastric Cancer Association anatomical classification. | |
| M cohort | Patients with non-E tumors centered in the middle third of the stomach according to the Japanese Gastric Cancer Association anatomical classification. | |
| L cohort | Patients with non-E tumors centered in the lower third of the stomach according to the Japanese Gastric Cancer Association anatomical classification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Station-specific lymph node metastasis rates stratified by ycT and ycN categories
For each E, U, M, and L tumor-location cohort and each prespecified lymph node station, the metastasis rate will be calculated as the number of patients with pathologically confirmed metastasis at that station divided by the number of patients in whom that station was actually dissected and had an evaluable station-specific pathological record. Rates will be reported across the complete AJCC/UICC eighth-edition ycT and ycN categories. Stations not dissected or not verifiably recorded will be excluded from the station-specific denominator and will not be classified as negative.
Measured: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Secondary outcomes (2)
Station-specific lymph node metastasis rates stratified by ypT, ypN, and tumor regression grade
Station-specific metastasis rates will be estimated according to postoperative ypT category, ypN category, and standardized tumor regression grade, using only patients with evaluable station-specific pathological records.
Measured: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Numbers of examined and metastatic lymph nodes according to tumor location
The total number of examined lymph nodes and the total number of pathologically metastatic lymph nodes will be summarized for the E, U, M, and L tumor-location cohorts and by gastrectomy type.
Measured: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Lianyungang, The Affiliated Hospital of Qingdao University, Hebei Medical University Fourth Hospital, The First Affiliated Hospital of Soochow University, Jiangsu Cancer Institute & Hospital, Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Hao Xu, MD, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902596
- Sponsor's protocol ID
- FNMU-NA-LND-2026-01
- Acronym
- NA-LND-GC
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the ethic requirements of multicentered study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Extent of Lymph Node Dissection After Neoadjuvant Therapy for Gastric and Esophagogastric Junction Adenocarcinoma: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07902596
- Acronym / sponsor ID
- NA-LND-GC / FNMU-NA-LND-2026-01
- Keywords
- Neoadjuvant Therapy, Lymph Node Metastasis, Lymph Node Dissection, Gastric Cancer, Esophagogastric Junction Cancer, Preoperative Staging, Multicenter Retrospective Cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First People's Hospital of Lianyungang, The Affiliated Hospital of Qingdao University, Hebei Medical University Fourth Hospital, The First Affiliated Hospital of Soochow University, Jiangsu Cancer Institute & Hospital, Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter retrospective observational cohort study will evaluate approximately 2,000 adults with gastric or esophagogastric junction adenocarcinoma who received at least two cycles of neoadjuvant therapy followed by R0 gastrectomy with lymph node dissection. The study will estimate the frequency of pathological metastasis at individual lymph node stations according to the final preoperative imaging-based ycT and ycN categories and tumor location. The findings are intended to provide evidence for future prospective studies of risk-adapted reduction of perigastric lymph node dissection. No treatment is assigned by this study.
Detailed description
This study will retrospectively collect de-identified clinical, imaging, operative, and pathological data from participating centers. Eligible operations will have been performed from January 1, 2021, through August 30, 2026. Neoadjuvant regimens may include chemotherapy, chemotherapy combined with immunotherapy, or chemoradiotherapy; patients treated with conversion therapy or intraperitoneal hyperthermic perfusion will not be included.
The last preoperative staging assessment must be completed within four weeks before surgery. The routine ycT and ycN categories will be determined by each center's multidisciplinary team, primarily using contrast-enhanced computed tomography and supplemented by endoscopy, endoscopic ultrasonography, or positron emission tomography-computed tomography when clinically indicated. De-identified final preoperative imaging will undergo independent blinded central review by two experienced gastric cancer radiologists, with discrepancies resolved by consensus. The central review ycT and ycN categories will be used for the primary analysis, and local multidisciplinary staging will be examined in sensitivity analyses. Staging will follow the eighth edition of the AJCC/UICC system. Only patients with ycM0 disease will be eligible.
Tumors will be classified into four mutually exclusive location cohorts. The E cohort includes tumors whose upper margin reaches or crosses the esophagogastric junction, or for which endoscopy explicitly reports an unclear, immediately adjacent, or involved dentate line. Other gastric tumors will be classified as U, M, or L according to the upper, middle, or lower third of the stomach under the Japanese Gastric Cancer Association anatomical system; tumors spanning more than one region will be assigned according to the location of the tumor center.
Station-specific pathological data will include No. 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 10, 11p, 11d, and 12a lymph nodes, with other para-aortic, abdominal, or mediastinal stations recorded separately. For each station, the denominator will include only patients in whom that station was actually dissected and had an evaluable station-specific pathological record. A station that was not dissected or could not be confirmed will be excluded from that station's denominator and will not be assumed to be pathologically negative.
Data will be entered into a standardized case report form, de-identified locally, and transferred to the coordinating center for centralized quality control and analysis. Additional participating centers may be added after registration. Station-specific metastasis proportions will be reported with Clopper-Pearson exact 95% confidence intervals. Group comparisons will use chi-square or Fisher exact tests as appropriate. Multilevel analyses will account for center effects, and exploratory comparisons across multiple nodal stations will use the Benjamini-Hochberg false discovery rate procedure. Firth penalized regression or exact estimates will be used for sparse outcomes; conventional multivariable models will be limited to outcomes with adequate event counts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E cohort | – | –Patients with tumors whose upper margin reaches or crosses the esophagogastric junction, or whose endoscopy report explicitly describes an unclear, immediately adjacent, or involved dentate line. |
| U cohort | – | –Patients with non-E tumors centered in the upper third of the stomach according to the Japanese Gastric Cancer Association anatomical classification. |
| M cohort | – | –Patients with non-E tumors centered in the middle third of the stomach according to the Japanese Gastric Cancer Association anatomical classification. |
| L cohort | – | –Patients with non-E tumors centered in the lower third of the stomach according to the Japanese Gastric Cancer Association anatomical classification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults treated at participating tertiary hospitals in China who underwent surgery from January 1, 2021, through August 30, 2026, for histologically confirmed gastric or esophagogastric junction adenocarcinoma after neoadjuvant therapy.
Key inclusion criteria (8 listed)
- Age 18 years or older.
- Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma.
- Completion of at least two cycles of neoadjuvant chemotherapy, chemotherapy combined with immunotherapy, or chemoradiotherapy.
- Final preoperative imaging assessment within four weeks before surgery with evaluable ycT and ycN categories according to the AJCC/UICC eighth edition.
- ycM0 disease before surgery.
Key exclusion criteria (9 listed)
- Histological diagnosis other than adenocarcinoma, including squamous cell carcinoma, lymphoma, gastrointestinal stromal tumor, or neuroendocrine neoplasm.
- Conversion therapy for initially unresectable or metastatic disease.
- Intraperitoneal hyperthermic perfusion treatment.
- ycM1 disease, including peritoneal, hepatic, or other distant metastasis.
- R1 or R2 resection, palliative surgery, or exploratory surgery without curative gastrectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Station-specific lymph node metastasis rates stratified by ycT and ycN categories
Time frame: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
For each E, U, M, and L tumor-location cohort and each prespecified lymph node station, the metastasis rate will be calculated as the number of patients with pathologically confirmed metastasis at that station divided by the number of patients in whom that station was actually dissected and had an evaluable station-specific pathological record. Rates will be reported across the complete AJCC/UICC eighth-edition ycT and ycN categories. Stations not dissected or not verifiably recorded will be excluded from the station-specific denominator and will not be classified as negative.
2 secondary outcomes
Station-specific lymph node metastasis rates stratified by ypT, ypN, and tumor regression grade
Time frame: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Numbers of examined and metastatic lymph nodes according to tumor location
Time frame: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. Due to the ethic requirements of multicentered study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao Xu, MD, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma and Esophagogastric Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Xu, MD, PhD (+86-25-68306505, hxu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Station-specific lymph node metastasis rates stratified by ycT and ycN categories (time frame: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.