Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

Last updated: January 5, 2025
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

MRD-guided therapy

Clinical Study ID

NCT06157216
MRD-GATE
  • Ages 18-75
  • All Genders

Study 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 stage II-III gastric cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have undergone D2 gastrectomy, achieved R0 resection, and arepathologically diagnosed with stage II-III gastric cancer.

  2. No preoperative neoadjuvant or adjuvant therapy received.

  3. Voluntary participation with signed informed consent, demonstrating good complianceand 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 ofnormal. 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

Exclusion Criteria:

  1. Pregnant or lactating women, or women of childbearing potential with a positivepregnancy 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 skincancers, 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 myocardialinfarction within the last 12 months.

  8. Uncontrolled infection, severe kidney disease, or other significant concurrentdiseases.

  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 studytreatment 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 ortrial compliance, including serious illnesses requiring treatment, severe laboratoryabnormalities, or other social or family reasons.

Study Design

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: MRD-guided therapy
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
April 01, 2029

Connect with a study center

  • Jinan Central Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Qilu Hospital of Shandong Univertisy

    Jinan, Shandong 250012
    China

    Site Not Available

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong 250012
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264000
    China

    Site Not Available

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