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Clinical Trials in China / NCT06157216
Active, not recruiting Not applicable

Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

NCT06157216 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Not applicable
Started
2023-10-01
Last updated
2026-05-18

Condition(s) studied

Stage II-III Gastric Cancer

Investigational drug(s) / intervention(s)

MRD-guided therapy

MRD-guided therapy: MRD negative stage II gastric cancer: Observation; MRD negative stage III gastric cancer: S1 (40-60 mg, PO, bid, d1-d14 q3w); MRD positive stage II/III gastric cancer: XELOX (Oxaliplatin 130mg/m2, d1 +Capecitabine 1000mg/m2,PO. bid, d1-14, q3w) or SOX (Oxaliplatin 130mg/m2, d1 +S-1 40-60 mg, PO. bid, d1-14, q3w); MRD-negative patients will receive XELOX or SOX if MRD becomes positive.

Study summary

This is a single-arm, interventional study to explore the feasibility of circulating tumor DNA (ctDNA)-MRD testing to guide postoperative adjuvant treatment strategies in patients with stage II-III gastric cancer.

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 NCT06157216 on ClinicalTrials.gov ↗ ← All trials in China