NCT06157216Active, not recruiting
Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer
Circulating Tumor DNA Minimal Residual Disease-guided Adjuvant Chemotherapy in Patients With Stage II-III Gastric Cancer
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 19 Nov 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06157216
What you commit to
- Study type: Interventional
- Planned participants: 65
- From 1 Oct 2023 to the primary completion date, 1 Apr 2027
- 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 · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong Univertisy Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.