Status:
ACTIVE_NOT_RECRUITING
Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
Shandong Provincial Hospital
Jinan Central Hospital
Conditions:
Stage II-III Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a multicenter, single-arm, interventional study to explore the feasibility of circulating tumor DNA (ctDNA)-MRD testing to guide postoperative adjuvant treatment strategies in patients with st...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
- Evidence of postoperative recurrence or metastasis.
- Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
- Positive resection margins identified in postoperative pathology.
- History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
- Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
- Allergic reactions to study drugs.
- 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.
- Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
- Positive for COVID-19 nucleic acid or antigen test.
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06157216
Start Date
October 1 2023
End Date
April 1 2029
Last Update
January 7 2025
Active Locations (5)
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1
Qilu Hospital of Shandong Univertisy
Jinan, Shandong, China, 250012
2
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250012
3
Jinan Central Hospital
Jinan, Shandong, China
4
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000