Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer

Last updated: September 21, 2024
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Gastric Cancer

Stomach Cancer

Treatment

Standard chemotherapy regimen

Clinical Study ID

NCT06609759
MRD2
  • Ages 18-75
  • All Genders

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 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: 197
Treatment Group(s): 1
Primary Treatment: Standard chemotherapy regimen
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
January 01, 2029

Connect with a study center

  • Jinan Central Hospital,

    Jinan, Shandong
    China

    Active - Recruiting

  • Qilu Hospital of Shandong Univertisy

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264000
    China

    Active - Recruiting

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