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NCT06609759Active, not recruiting

Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer

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

Source: ClinicalTrials.gov · Last updated 5 May 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
197 (estimated)
First submitted
18 Sept 2024
Start date
Jan 2024
Primary completion date
Jan 2028
Lead sponsor
Qilu Hospital of Shandong University
NCT number
NCT06609759

What you commit to

  • Study type: Observational
  • Planned participants: 197
  • From Jan 2024 to the primary completion date, Jan 2028
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
  • Positive resection margins identified in postoperative pathology.
  • Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
  • Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
  • 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.

Other illness

  • History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
  • Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
  • Allergic reactions to study drugs.
  • Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
  • Positive for COVID-19 nucleic acid or antigen test.

Lab values

  • 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.

Other

  • Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
  • Evidence of postoperative recurrence or metastasis.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites.

Who the study is looking for

  • Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
  • No preoperative neoadjuvant or adjuvant therapy received.
  • Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
  • Age between 18-75 years, with no gender restrictions.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Estimated survival of 6 months or more.
  • 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).

Age in the registry: 18 years to 75 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Qilu Hospital of Shandong Univertisy
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Jinan Central Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
The Affiliated Hospital of Qingdao University
Coordinator of this site? Confirm its status
QingdaoChinaUnknown status
Yantai Yuhuangding Hospital
Coordinator of this site? Confirm its status
YantaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.