A Phase 2 interventional study of Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection and Gastrectomy with standard D2 lymphadenectomy in Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
Some patients with gastric cancer have enlarged para-aortic lymph nodes, also called No. 16 lymph nodes, at diagnosis. After standard chemoimmunotherapy, these lymph nodes may shrink to less than 10 mm on imaging, but it is uncertain whether microscopic cancer remains and whether surgically removing these nodes improves disease control. This single-center randomized exploratory trial will enroll 32 patients whose suspicious No. 16a2 and/or No. 16b1 lymph nodes have regressed to less than 10 mm after 2 to 8 cycles of standard chemoimmunotherapy and who have no disease progression or new distant metastases. Participants will be assigned 1:1 to curative-intent gastrectomy with standard D2 lymphadenectomy either with or without para-aortic lymph node dissection. The main outcome is progression-free survival at 2 years after randomization.
PAN-SELECT is a prospective, open-label, parallel-group, single-center randomized exploratory trial. The study evaluates whether adding dissection of the No. 16a2 and No. 16b1 para-aortic lymph nodes to curative-intent gastrectomy and standard D2 lymphadenectomy improves outcomes in a response-selected population with gastric or eligible esophagogastric junction adenocarcinoma.
At initial diagnosis, eligible candidates must have radiologic evidence of involvement of No. 16a2 and/or No. 16b1 lymph nodes, defined by a short-axis diameter of at least 10 mm together with metastatic morphology, and no other distant metastases. Candidates receive 2 to 8 cycles of an immune checkpoint inhibitor combined with chemotherapy as routine clinical care outside the randomized intervention. The specific agents, doses, modifications, and number of cycles are selected by the multidisciplinary team according to current clinical practice and are recorded by the study.
After completion of the planned preoperative systemic therapy, chest, abdominal, and pelvic contrast-enhanced computed tomography is performed. Written informed consent for PAN-SELECT is obtained only after the first planned post-treatment reassessment confirms that all previously suspicious No. 16a2 and No. 16b1 lymph nodes have a short-axis diameter of less than 10 mm, there is no progression according to RECIST version 1.1 and clinical assessment, there is no new distant metastasis, curative-intent R0 resection appears feasible, and the patient is fit for either study operation.
After all randomization criteria are verified, an independent statistician-generated sequence using simple randomization with a fixed seed assigns participants 1:1 to one of two groups. The experimental group undergoes gastrectomy with standard D2 lymphadenectomy plus systematic dissection of No. 16a2 and No. 16b1 para-aortic lymph nodes. The active comparator group undergoes gastrectomy with standard D2 lymphadenectomy without planned systematic No. 16 dissection. Robotic, laparoscopic, and open approaches are permitted. Surgery is planned 2 to 6 weeks after the last preoperative systemic treatment, after treatment-related toxicity has recovered and the participant is clinically fit.
Participants and surgeons are not masked because the surgical fields differ. Radiologic progression and recurrence are independently assessed by two radiologists who are not involved in clinical decision-making and are unaware of treatment assignment; disagreement is resolved by a third radiologist or multidisciplinary review. Pathology reporting includes ypTNM stage, Becker or College of American Pathologists tumor regression grade, margin and R0 status, and regional lymph node station-specific counts. In the experimental group, the No. 16 specimen is submitted separately and the number of examined and metastatic No. 16 lymph nodes is recorded.
The primary estimand is the between-group difference in 2-year progression-free survival under the intention-to-treat principle. The sample size of 32 participants is based on single-center feasibility and the precision needed for preliminary estimates rather than a formal superiority or noninferiority hypothesis test. Results will be used to estimate effect size, event rates, surgical safety, protocol adherence, and recruitment feasibility for a future multicenter confirmatory trial.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 32 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
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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.
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.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
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.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Participants undergo curative-intent gastrectomy with standard D2 lymphadenectomy plus systematic para-aortic lymph node dissection of No. 16a2 and No. 16b1. The No. 16 specimen is submitted separately for pathological examination.
Procedure: Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection
Participants undergo curative-intent gastrectomy with standard D2 lymphadenectomy without planned systematic dissection of No. 16a2 or No. 16b1. Rescue removal or dissection is permitted only when an intraoperative finding requires treatment for safety or curative intent, and the reason and extent are recorded.
Procedure: Gastrectomy with standard D2 lymphadenectomy
Distal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and additional systematic dissection of No. 16a2 from the upper border of the celiac trunk to the lower border of the left renal vein and No. 16b1 from the lower border of the left renal vein to the upper border of the inferior mesenteric artery. Robotic, laparoscopic, or open surgery is permitted.
Distal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and without planned systematic No. 16a2 or No. 16b1 dissection. Robotic, laparoscopic, or open surgery is permitted.
Progression-free survival rate at 2 years
Progression-free survival is measured from randomization to the earliest of radiologic or clinical disease progression, postoperative local, regional, or distant recurrence, or death from any cause. Participants without an event are censored at the date of their last adequate disease assessment. The 2-year progression-free survival rate will be estimated by the Kaplan-Meier method.
Time frame: From randomization to 2 years after randomization
Recurrence-free survival rate at 2 years after surgery
Among participants who undergo R0 resection, recurrence-free survival is measured from surgery to the earliest of local, regional, or distant recurrence or death from any cause. Participants without an event are censored at the date of their last adequate disease assessment.
Time frame: From surgery to 2 years after surgery
Overall survival
Overall survival is measured from randomization to death from any cause. Participants alive at the last follow-up are censored on that date.
Time frame: From randomization through 5 years after surgery
Cumulative incidence of para-aortic lymph node region recurrence
Recurrence involving the No. 16a2 or No. 16b1 region is determined by imaging, pathology, or clinical evidence. The cumulative incidence will be estimated with death without para-aortic recurrence treated as a competing event, and recurrence patterns will be summarized.
Time frame: From randomization through 5 years after surgery
R0 resection rate
The percentage of randomized participants with microscopically negative proximal, distal, and applicable circumferential or other resection margins.
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Pathological complete response rate
The percentage of participants with no residual viable tumor in the gastric primary tumor and all evaluated lymph nodes, defined as ypT0N0.
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Number of examined and metastatic regional lymph nodes
Regional lymph nodes will be recorded by station, including the number examined and the number with pathologically confirmed metastasis.
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Pathological positivity rate of No. 16 para-aortic lymph nodes in the experimental arm
Among participants assigned to D2 lymphadenectomy plus para-aortic lymph node dissection who have an evaluable No. 16 specimen, the percentage with at least one pathologically metastatic No. 16 lymph node and the numbers examined and metastatic will be reported.
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Operative time
Operative time in minutes, measured according to the institutional anesthesia and operative record, will be summarized by randomized group.
Time frame: During the assigned surgery
Estimated intraoperative blood loss
Estimated blood loss in milliliters, as recorded in the operative and anesthesia records, will be summarized by randomized group.
Time frame: During the assigned surgery
Postoperative length of hospital stay
The number of days from surgery to hospital discharge will be summarized by randomized group.
Time frame: From surgery until discharge, generally within 30 days after surgery
Rate of Clavien-Dindo grade III or higher postoperative complications
The percentage of participants with at least one postoperative complication requiring surgical, endoscopic, or radiologic intervention, intensive care for organ dysfunction, or resulting in death, classified as Clavien-Dindo grade III or higher.
Time frame: Within 30 days after surgery
All-cause postoperative mortality
The percentage of participants who die from any cause within 90 days after surgery.
Time frame: Within 90 days after surgery
Plan to share: No — Due to ethic restriction.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital with Nanjing Medical University →