Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

NCT ID: NCT06157216

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2029-04-01

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 stage II-III gastric cancer.

Conditions

Stage II-III Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRD-guided treatment

Patients post-surgery will receive MRD tests and receive MRD-guided adjuvant therapies. After that, MRD status will be continuously monitored for three years to guide the following therapies.

Group Type: EXPERIMENTAL

MRD-guided therapy

Intervention Type: DRUG

MRD negative stage II gastric cancer: Observation; MRD negative stage III gastric cancer: S1 (40-60 mg, PO, bid, d1-d14 q3w); MRD positive stage II/III gastric cancer: XELOX (Oxaliplatin 130mg/m2, d1 +Capecitabine 1000mg/m2，PO. bid, d1-14, q3w) or SOX (Oxaliplatin 130mg/m2, d1 +S-1 40-60 mg, PO. bid, d1-14, q3w); MRD-negative patients will receive XELOX or SOX if MRD becomes positive.

Interventions

MRD-guided therapy

MRD negative stage II gastric cancer: Observation; MRD negative stage III gastric cancer: S1 (40-60 mg, PO, bid, d1-d14 q3w); MRD positive stage II/III gastric cancer: XELOX (Oxaliplatin 130mg/m2, d1 +Capecitabine 1000mg/m2，PO. bid, d1-14, q3w) or SOX (Oxaliplatin 130mg/m2, d1 +S-1 40-60 mg, PO. bid, d1-14, q3w); MRD-negative patients will receive XELOX or SOX if MRD becomes positive.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Jinan Central Hospital

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital of Shandong Univertisy

Jinan, Shandong, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Countries

China

Other Identifiers

MRD-GATE

Identifier Type: -

Identifier Source: org_study_id