Circulating Tumor DNA Minimal Residual Disease-guided Adjuvant Chemotherapy in Patients With Stage II-III Gastric Cancer

Qilu Hospital of Shandong University5 sites in 1 country85 target enrollmentOctober 1, 2023

ConditionsStage II-III Gastric Cancer

InterventionsMRD-guided therapy

DrugsMRD-guided therapy

Overview

Phase: Not Applicable
Intervention: MRD-guided therapy
Conditions: Stage II-III Gastric Cancer
Sponsor: Qilu Hospital of Shandong University
Enrollment: 85
Locations: 5
Primary Endpoint: 3-year Disease-Free Survival (DFS) rate
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2023

End Date

April 1, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Qilu Hospital of Shandong University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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-
•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 Criteria

•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.

Arms & Interventions

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.

Intervention: MRD-guided therapy

Outcomes

Primary Outcomes

3-year Disease-Free Survival (DFS) rate

Time Frame: 3-year after the last subject participating in

The 3-year DFS rate is defined as the percentage of patients who remain free of tumor recurrence or death within three years after surgery.

Secondary Outcomes

Cumulative Risk of Recurrence(3-year after the last subject participating in)
3-year Overall Survival (OS) Rate(3-year after the last subject participating in)
Disease-Free Survival (DFS)(3-year after the last subject participating in)
Rate of De-escalation Treatment(3-year after the last subject participating in)