Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer

May 2, 2026 updated by: Lian Liu, MD, PHD, Qilu Hospital of Shandong University

Efficacy and Safety of Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer: a Prospective, Observational Study

For patients with stage II-III gastric cancer after radical D2 resection and R0 resection, postoperative adjuvant therapy guided by ctDNA-MRD (MRD-GATE external cohort) was not inferior to the standard chemotherapy regimen (this cohort).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lian Liu, M.D., Ph.D.
  • Phone Number: +8653182169851
  • Email: tounao@126.com

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu hospital of Shandong univertisy
      • Jinan, Shandong, China, 250012
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
      • Jinan, Shandong, China
        • Jinan Central Hospital,
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital Of Qingdao University
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

D2 gastrectomy followed by R0 resection, and postoperative pathology confirmed stage II-III gastric cancer

Description

Inclusion Criteria:

  1. Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
  2. No preoperative neoadjuvant or adjuvant therapy received.
  3. Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
  4. Age between 18-75 years, with no gender restrictions.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  6. Estimated survival of 6 months or more.
  7. Baseline hematological and biochemical parameters within specified limits: a. Hemoglobin ≥ 80g/L. b. Absolute neutrophil count ≥ 1.5×10^9/L. c. Platelet count ≥ 100×10^9/L. d. Aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal. e. Alkaline phosphatase ≤ 2.5 times the upper limit of normal. f. Thyroid-stimulating hormone (TSH) ≤ 1 times the upper limit of normal (if abnormal, T3 and T4 levels must be normal).

Exclusion Criteria:

  1. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
  2. Evidence of postoperative recurrence or metastasis.
  3. Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
  4. Positive resection margins identified in postoperative pathology.
  5. History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
  6. Uncontrolled pleural effusion, pericardial effusion, or ascites.
  7. Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
  8. Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
  9. Allergic reactions to study drugs.
  10. Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
  11. Administration of live attenuated vaccines within 4 weeks prior to the first study treatment dose or plans to receive such vaccines during the study period.
  12. Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
  13. Positive for COVID-19 nucleic acid or antigen test.
  14. Other conditions deemed by the investigator to potentially affect patient safety or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Standard chemotherapy regimen
Drug: Standard chemotherapy regimen
In terms of postoperative adjuvant treatment, treatment is based on the guideline standard treatment plan, which can be adjusted according to the doctor's experience.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-year Disease-Free Survival (DFS) rate
Time Frame: 3-year after the last subject participating in
The 3-year DFS rate is defined as the percentage of patients who remain free of tumor recurrence or death within three years after surgery.
3-year after the last subject participating in

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of De-escalation Treatment
Time Frame: 3-year after the last subject participating in
The Rate of De-escalation Treatment is defined as the proportion of patients among a study population who receive a reduction in the intensity or scope of therapeutic interventions.
3-year after the last subject participating in
Disease-Free Survival (DFS)
Time Frame: 3-year after the last subject participating in
Disease-Free Survival (DFS) is defined as the duration of time from the initiation of surgery until the recurrence of the disease or death from any cause, whichever comes first.
3-year after the last subject participating in
Cumulative Risk of Recurrence
Time Frame: 3-year after the last subject participating in
The Cumulative Risk of Recurrence is defined as the cumulative probability or risk of disease recurrence over a specified period, considering the entire study population.
3-year after the last subject participating in
3-year Overall Survival (OS) Rate
Time Frame: 3-year after the last subject participating in
3-year Overall Survival (OS) Rate is defined as the percentage of patients who are still alive three years after the initiation of a specific treatment, regardless of disease recurrence or progression.
3-year after the last subject participating in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Hospital of Qingdao University
Shandong Provincial Hospital
Jinan Central Hospital
Yantai Yuhuangding Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRD2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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