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Clinical Trials in China / NCT06609759
Active, not recruiting Observational

Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer

NCT06609759 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Observational
Started
2024-01-01
Last updated
2026-05-05

Condition(s) studied

Stage II-III Gastric Cancer

Investigational drug(s) / intervention(s)

Standard chemotherapy regimen

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.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Qilu Hospital of Shandong Univertisy Jinan Shandong
Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong
Jinan Central Hospital, Jinan Shandong
The Affiliated Hospital of Qingdao University Qingdao Shandong
Yantai Yuhuangding Hospital Yantai Shandong

More Qilu Hospital of Shandong University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06609759 on ClinicalTrials.gov ↗ ← All trials in China