This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma. After curative-intent surgery, patients remain at risk of disease recurrence. Postoperative treatment decisions are currently based on clinicopathological factors, which may not fully reflect minimal residual disease. ctDNA is a blood-based biomarker that can detect tumor-derived DNA fragments and may provide additional information on recurrence risk. In this study, ctDNA will be assessed at predefined perioperative and postoperative time points using peripheral blood samples. The primary objective is to evaluate 1-year disease-free survival. Secondary objectives include survival outcomes, safety, and longitudinal changes in ctDNA status. The findings of this exploratory study may inform future research on ctDNA-guided postoperative management in gastric cancer.
This is a single-center, prospective, exploratory study designed to evaluate the feasibility and clinical value of using dynamic circulating tumor DNA (ctDNA) testing to guide postoperative adjuvant treatment in patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma. After curative-intent surgery, patients remain at risk of disease recurrence. Currently, postoperative adjuvant treatment decisions are mainly based on clinical and pathological factors, which may not fully reflect the presence of minimal residual disease. ctDNA is a blood-based biomarker that can detect small amounts of tumor-derived DNA and may provide additional information about recurrence risk after surgery. In this study, ctDNA will be dynamically assessed at predefined perioperative and postoperative time points using peripheral blood samples. The study aims to explore the association between postoperative ctDNA status and disease outcomes, as well as the potential role of ctDNA monitoring in postoperative adjuvant treatment management. The primary objective of this study is to evaluate disease-free survival at 1 year. Secondary objectives include assessment of survival outcomes, safety, and changes in ctDNA status over time. The results of this exploratory study are expected to provide preliminary evidence to support further clinical research on ctDNA-guided adjuvant treatment strategies in gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
HLX10 is a programmed death-1 (PD-1) monoclonal antibody administered as postoperative adjuvant treatment
SOX chemotherapy consists of S-1 in combination with oxaliplatin and is administered as part of postoperative adjuvant treatment
1 year Disease-Free Survival rate
Disease-Free Survival rate at 1 year
Time frame: Up to 1 year after surgery
Disease Control Rate
the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1.
Time frame: During perioperative treatment
Major Pathological Response (MPR) Rate
the proportion of patients with ≤10% residual viable tumor cells in the resected tumor specimen, as assessed by pathological examination after surgery
Time frame: At the time of surgery
3-year Disease-Free Survival Rate
the proportion of patients who remain alive without disease recurrence or metastasis within 3 years after surgery.
Time frame: Up to 3 years after surgery
5-year Disease-Free Survival Rate
the proportion of patients who remain alive without disease recurrence or metastasis within 5 years after surgery.
Time frame: Up to 5 years after surgery
Median Disease-Free Survival
Median disease-free survival (mDFS) is defined as the time from the date of surgery to the date of first documented local or distant recurrence, diagnosis of a new primary malignancy, or death from any cause, whichever occurs first. mDFS is the time point at which 50% of patients remain disease-free.
Time frame: Up to 5 years after surgery
Overall Survival
the time from study enrollment to death from any cause.
Time frame: Up to 5 years after enrollment
adverse events
Safety is assessed by the incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
Time frame: From the first dose of study treatment up to 90 days after the last dose
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