Gastric AdenocarcinomaNCT07799649
ctDNA-MRD Monitoring After Neoadjuvant Therapy in Gastric Cancer With pCR or MPR
An observational study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This prospective observational study will enroll adults with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Tumor-Informed ctDNA-MRD Monitoring and Clinician-Selected Standard-of-Care Postoperative Treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Apr 2032
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults treated at The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have completed neoadjuvant therapy, undergone R0 gastrectomy, and achieved pathological complete response or major pathological response.
Who may be able to join
- Age 18 to 75 years.
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Completion of preoperative neoadjuvant therapy followed by R0 gastrectomy.
- Postoperative pathological complete response, defined as Becker tumor regression grade 1a or Ryan tumor regression grade 0, or major pathological response, defined as Becker tumor regression grade 1b or Ryan tumor regression grade 1 with 10 percent or less residual viable tumor.
- Willingness to undergo serial blood collection and follow-up and provision of written informed consent.
- Eastern Cooperative Oncology Group performance status of 0 or 1 with adequate major organ function.
- Adequate diagnostic biopsy or preoperative tumor tissue for 1021-gene panel testing.
Who cannot join
- Postoperative pathological assessment showing neither pathological complete response nor major pathological response, including more than 10 percent residual viable tumor or Becker tumor regression grade 2 to 3.
- Distant metastatic disease identified intraoperatively or postoperatively.
- Another malignant tumor within the previous 5 years.
- Severe postoperative complications preventing any postoperative antitumor therapy.
- Contraindication to immunotherapy, including active autoimmune disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Nanjing, Jiangsu, 210029
Hao Xu, +8617521597055, hxu@njmu.edu.cn
Hao Xu
About this study
Official title: A Prospective, Single-Center Observational Study Evaluating Recurrence Risk Using ctDNA-Based Molecular Residual Disease Monitoring in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma Achieving Pathological Complete Response or Major Pathological Response After Neoadjuvant Therapy
This prospective observational study will enroll adults with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. The study will evaluate whether postoperative circulating tumor DNA-based molecular residual disease status can identify participants at increased risk of recurrence despite a favorable pathological response. All postoperative treatment decisions will be made by the treating clinicians according to routine care and will not be assigned by the study. Tumor-informed ctDNA-MRD testing will be performed longitudinally, and results will not be used to alter treatment. Participants will be followed for disease-free survival, overall survival, recurrence detection, and adverse events.
Read the detailed description
This is a prospective, single-center, noninterventional real-world cohort study in participants with locally advanced gastric or gastroesophageal junction adenocarcinoma who have completed neoadjuvant therapy, undergone R0 gastrectomy, and achieved pathological complete response or major pathological response.
The primary objective is to assess the prognostic stratification value of postoperative ctDNA-based molecular residual disease status. Secondary objectives are to compare disease-free survival across clinician-selected postoperative adjuvant treatment strategies among ctDNA-MRD-negative participants, evaluate the diagnostic performance and lead time of ctDNA-MRD monitoring for recurrence, and describe adverse events associated with routine postoperative treatment.
The tumor-informed ctDNA-MRD assay will use somatic variants identified from diagnostic biopsy or resection tissue to construct an individualized monitoring panel. Plasma cell-free DNA will undergo ultra-deep sequencing with molecular error correction. A negative result is defined as no stable detection of tumor-derived variants at an allele frequency of 0.02 percent or higher in a quality-controlled sample with adequate cell-free DNA input. Blood is planned before surgery, approximately 1 month after surgery before adjuvant treatment, approximately 3 months after surgery or after completion of adjuvant chemotherapy, and subsequently every 3 to 6 months when feasible. ctDNA-MRD results are intended for correlative analysis and will not direct changes in clinical treatment.
Postoperative adjuvant therapy will be selected by treating clinicians according to applicable guidelines, pathological and molecular features, treatment tolerance, multidisciplinary discussion, participant preference, and financial considerations. The study will not randomize participants or assign therapy. Imaging and survival follow-up will occur every 3 months during the first postoperative year and every 3 to 6 months thereafter through 3 years after surgery or until recurrence or death. Analyses will include Kaplan-Meier estimates, Cox proportional hazards models, and propensity score methods to address measured confounding in comparisons of treatment strategies.
- Being tested
- Tumor-Informed ctDNA-MRD Monitoring, Clinician-Selected Standard-of-Care Postoperative Treatment
- Keywords
- Circulating Tumor DNA, Molecular Residual Disease, Pathological Complete Response, Major Pathological Response, Neoadjuvant Therapy, Recurrence Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor-Informed ctDNA-MRD MonitoringDiagnostic test
Also called Circulating tumor DNA-based molecular residual disease monitoring
Patient-specific somatic variants identified from tumor tissue are used to construct an individualized panel for ultra-deep sequencing of plasma cell-free DNA at prespecified perioperative and follow-up time points. Results are used for observational correlation and do not guide treatment changes.
Clinician-Selected Standard-of-Care Postoperative TreatmentOther
Postoperative treatment is selected by treating clinicians according to guidelines and individual clinical factors. The study does not assign, randomize, or modify treatment.
| Study group | Role | What they receive |
|---|---|---|
| Prospective pCR/MPR Cohort | Participants with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. All participants undergo longitudinal ctDNA-MRD monitoring and receive clinician-selected standard-of-care postoperative management. Receives: Diagnostic Test: Tumor-Informed ctDNA-MRD Monitoring; Other: Clinician-Selected Standard-of-Care Postoperative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-Year Disease-Free Survival Rate
Disease-free survival is defined as the time from R0 gastrectomy to the first documented tumor recurrence or death from any cause, whichever occurs first. Participants without an event will be censored at the last disease assessment. The 3-year disease-free survival rate will be estimated using the Kaplan-Meier method.
Measured: From R0 gastrectomy through 3 years after surgery
Secondary outcomes (5)
Three-Year Overall Survival Rate
Overall survival is defined as the time from R0 gastrectomy to death from any cause. Participants alive at the last follow-up will be censored on that date. The 3-year overall survival rate will be estimated using the Kaplan-Meier method.
Measured: From R0 gastrectomy through 3 years after surgery
Lead Time From ctDNA-MRD Detection to Radiographic Recurrence
Among participants with recurrence, lead time will be calculated as the interval in days between the first postoperative ctDNA-MRD-positive result and the first radiographically documented recurrence. Positive values indicate that ctDNA-MRD detection preceded radiographic recurrence.
Measured: From the first postoperative ctDNA-MRD assessment through 3 years after surgery
Sensitivity and Specificity of ctDNA-MRD for Postoperative Recurrence
Sensitivity and specificity of postoperative ctDNA-MRD status for detecting recurrence will be estimated using radiographic or clinically confirmed recurrence during follow-up as the reference standard.
Measured: From the first postoperative ctDNA-MRD assessment through 3 years after surgery
Three-Year Disease-Free Survival by Postoperative Adjuvant Treatment Strategy
Among postoperative ctDNA-MRD-negative participants with pathological complete response or major pathological response, disease-free survival will be compared across clinician-selected standard-of-care postoperative adjuvant treatment strategies. Treatment is not assigned by the study. Analyses will account for measured baseline confounding using propensity score methods and multivariable models.
Measured: From R0 gastrectomy through 3 years after surgery
Incidence of Adverse Events
The number and percentage of participants experiencing adverse events during routine postoperative treatment and follow-up will be summarized overall and by clinician-selected adjuvant treatment strategy.
Measured: From enrollment through 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Hao Xu, Principal investigator, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799649
- Sponsor's protocol ID
- 2026-SR-084
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center Observational Study Evaluating Recurrence Risk Using ctDNA-Based Molecular Residual Disease Monitoring in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma Achieving Pathological Complete Response or Major Pathological Response After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07799649
- Acronym / sponsor ID
- 2026-SR-084
- Keywords
- Circulating Tumor DNA, Molecular Residual Disease, Pathological Complete Response, Major Pathological Response, Neoadjuvant Therapy, Recurrence Risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 2 Sep 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 prospective observational study will enroll adults with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. The study will evaluate whether postoperative circulating tumor DNA-based molecular residual disease status can identify participants at increased risk of recurrence despite a favorable pathological response. All postoperative treatment decisions will be made by the treating clinicians according to routine care and will not be assigned by the study. Tumor-informed ctDNA-MRD testing will be performed longitudinally, and results will not be used to alter treatment. Participants will be followed for disease-free survival, overall survival, recurrence detection, and adverse events.
Detailed description
This is a prospective, single-center, noninterventional real-world cohort study in participants with locally advanced gastric or gastroesophageal junction adenocarcinoma who have completed neoadjuvant therapy, undergone R0 gastrectomy, and achieved pathological complete response or major pathological response.
The primary objective is to assess the prognostic stratification value of postoperative ctDNA-based molecular residual disease status. Secondary objectives are to compare disease-free survival across clinician-selected postoperative adjuvant treatment strategies among ctDNA-MRD-negative participants, evaluate the diagnostic performance and lead time of ctDNA-MRD monitoring for recurrence, and describe adverse events associated with routine postoperative treatment.
The tumor-informed ctDNA-MRD assay will use somatic variants identified from diagnostic biopsy or resection tissue to construct an individualized monitoring panel. Plasma cell-free DNA will undergo ultra-deep sequencing with molecular error correction. A negative result is defined as no stable detection of tumor-derived variants at an allele frequency of 0.02 percent or higher in a quality-controlled sample with adequate cell-free DNA input. Blood is planned before surgery, approximately 1 month after surgery before adjuvant treatment, approximately 3 months after surgery or after completion of adjuvant chemotherapy, and subsequently every 3 to 6 months when feasible. ctDNA-MRD results are intended for correlative analysis and will not direct changes in clinical treatment.
Postoperative adjuvant therapy will be selected by treating clinicians according to applicable guidelines, pathological and molecular features, treatment tolerance, multidisciplinary discussion, participant preference, and financial considerations. The study will not randomize participants or assign therapy. Imaging and survival follow-up will occur every 3 months during the first postoperative year and every 3 to 6 months thereafter through 3 years after surgery or until recurrence or death. Analyses will include Kaplan-Meier estimates, Cox proportional hazards models, and propensity score methods to address measured confounding in comparisons of treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective pCR/MPR Cohort | – | Diagnostic Test: Tumor-Informed ctDNA-MRD Monitoring, Other: Clinician-Selected Standard-of-Care Postoperative TreatmentParticipants with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. All participants undergo longitudinal ctDNA-MRD monitoring and receive clinician-selected standard-of-care postoperative management. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults treated at The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have completed neoadjuvant therapy, undergone R0 gastrectomy, and achieved pathological complete response or major pathological response.
Key inclusion criteria (7 listed)
- Age 18 to 75 years.
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Completion of preoperative neoadjuvant therapy followed by R0 gastrectomy.
- Postoperative pathological complete response, defined as Becker tumor regression grade 1a or Ryan tumor regression grade 0, or major pathological response, defined as Becker tumor regression grade 1b or Ryan tumor regression grade 1 with 10 percent or less residual viable tumor.
- Willingness to undergo serial blood collection and follow-up and provision of written informed consent.
Key exclusion criteria (5 listed)
- Postoperative pathological assessment showing neither pathological complete response nor major pathological response, including more than 10 percent residual viable tumor or Becker tumor regression grade 2 to 3.
- Distant metastatic disease identified intraoperatively or postoperatively.
- Another malignant tumor within the previous 5 years.
- Severe postoperative complications preventing any postoperative antitumor therapy.
- Contraindication to immunotherapy, including active autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor-Informed ctDNA-MRD MonitoringAlso: Circulating tumor DNA-based molecular residual disease monitoringPatient-specific somatic variants identified from tumor tissue are used to construct an individualized panel for ultra-deep sequencing of plasma cell-free DNA at prespecified perioperative and follow-up time points. Results are used for observational correlation and do not guide treatment changes. | Diagnostic test | Prospective pCR/MPR Cohort |
| Clinician-Selected Standard-of-Care Postoperative TreatmentPostoperative treatment is selected by treating clinicians according to guidelines and individual clinical factors. The study does not assign, randomize, or modify treatment. | Other | Prospective pCR/MPR Cohort |
Primary outcome
Three-Year Disease-Free Survival Rate
Time frame: From R0 gastrectomy through 3 years after surgery
Disease-free survival is defined as the time from R0 gastrectomy to the first documented tumor recurrence or death from any cause, whichever occurs first. Participants without an event will be censored at the last disease assessment. The 3-year disease-free survival rate will be estimated using the Kaplan-Meier method.
5 secondary outcomes
Three-Year Overall Survival Rate
Time frame: From R0 gastrectomy through 3 years after surgery
Lead Time From ctDNA-MRD Detection to Radiographic Recurrence
Time frame: From the first postoperative ctDNA-MRD assessment through 3 years after surgery
Sensitivity and Specificity of ctDNA-MRD for Postoperative Recurrence
Time frame: From the first postoperative ctDNA-MRD assessment through 3 years after surgery
Three-Year Disease-Free Survival by Postoperative Adjuvant Treatment Strategy
Time frame: From R0 gastrectomy through 3 years after surgery
Incidence of Adverse Events
Time frame: From enrollment through 3 years after surgery
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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
1 site 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 Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 7 inclusion and 5 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (+8617521597055, hxu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-Year Disease-Free Survival Rate (time frame: From R0 gastrectomy through 3 years after surgery). 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 2 Sep 2026.