Postoperative therapy for gastric cancer patients

Efficacy and Safety of Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer: a Prospective, Observational Study

This study tests if a new treatment plan based on blood tests for leftover cancer DNA can help patients with stage II-III gastric cancer feel better after surgery, compared to the usual chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 197 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 5 sites (Jinan, Shandong and 4 other locations)
• Trial ID: NCT06609759 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of postoperative adjuvant therapy guided by circulating tumor DNA minimal residual disease (ctDNA-MRD) in patients with stage II-III gastric cancer who have undergone radical D2 resection and achieved R0 resection. The approach compares this ctDNA-MRD guided therapy to the standard chemotherapy regimen to determine if it is non-inferior. The study aims to gather data on patient outcomes and treatment efficacy in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have undergone D2 gastrectomy for stage II-III gastric cancer and have achieved R0 resection without prior adjuvant therapy.

Not a fit: Patients who have received preoperative neoadjuvant or adjuvant therapy or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more personalized treatment option for gastric cancer patients, potentially improving outcomes after surgery.

How similar studies have performed: Other studies have shown promising results with ctDNA-guided therapies, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong and 4 other locations

• Qilu Hospital of Shandong Univertisy — Jinan, Shandong, China (RECRUITING)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (RECRUITING)
• Jinan Central Hospital, — Jinan, Shandong, China (RECRUITING)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (RECRUITING)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Lian Liu, M.D., Ph.D.

Conditions: Stage II-III Gastric Cancer