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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
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.
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
3-year Disease-Free Survival (DFS) rate
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.
Time frame: 3-year after the last subject participating in
Rate of De-escalation Treatment
The Rate of De-escalation Treatment is defined as the proportion of patients among a study population who receive a reduction in the intensity or scope of therapeutic interventions.
Time frame: 3-year after the last subject participating in
Disease-Free Survival (DFS)
Disease-Free Survival (DFS) is defined as the duration of time from the initiation of surgery until the recurrence of the disease or death from any cause, whichever comes first.
Time frame: 3-year after the last subject participating in
Cumulative Risk of Recurrence
The Cumulative Risk of Recurrence is defined as the cumulative probability or risk of disease recurrence over a specified period, considering the entire study population.
Time frame: 3-year after the last subject participating in
3-year Overall Survival (OS) Rate
3-year Overall Survival (OS) Rate is defined as the percentage of patients who are still alive three years after the initiation of a specific treatment, regardless of disease recurrence or progression.
Time frame: 3-year after the last subject participating in
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Yantai Yuhuangding Hospital
Yantai, Shandong, China