This study aims to evaluate the clinical value of circulating tumor DNA (ctDNA) as a minimally invasive biomarker for monitoring treatment response and guiding systemic therapy in patients with gastric or gastroesophageal junction adenocarcinoma. Gastric cancer is often diagnosed at an advanced stage and shows substantial biological heterogeneity. Current treatment decisions mainly rely on imaging and clinical assessment, which may not reflect early molecular changes or minimal residual disease. Circulating tumor DNA, released from tumor cells into the bloodstream, can provide real-time information on tumor burden and treatment response through simple blood sampling. This is a prospective, open-label, phase II exploratory study conducted at a single center. Patients will be enrolled into three clinical cohorts according to their treatment stage: (1) neoadjuvant or conversion therapy cohort, (2) adjuvant therapy cohort after curative surgery, and (3) advanced or metastatic disease cohort receiving systemic therapy. Blood samples for ctDNA analysis will be collected before treatment and at predefined time points during treatment. The study will assess whether changes in ctDNA levels, including ctDNA clearance or reduction, are associated with treatment response, recurrence risk, and survival outcomes. In selected validation phases, treatment strategies may be adjusted based on ctDNA results, while all treatments remain within standard guideline-recommended regimens. The results of this study may help determine whether ctDNA can be used as a practical tool to improve treatment monitoring and support more personalized management of gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Plasma circulating tumor DNA (ctDNA) will be analyzed using a targeted next-generation sequencing panel to assess tumor-specific genetic alterations. Blood samples will be collected at predefined time points during treatment. ctDNA dynamics, including clearance or changes in mutation allele frequency, will be used to evaluate molecular response and guide treatment decisions within standard-of-care options.
Participants will receive guideline-recommended systemic treatment according to disease stage and clinical practice, including neoadjuvant or conversion therapy, adjuvant chemotherapy, or systemic therapy for advanced disease. Treatment regimens may include fluoropyrimidine- and platinum-based chemotherapy, with or without PD-1 inhibitors or other standard agents. All treatments are administered according to standard-of-care and are not investigational.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGObjective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by investigators.
Time frame: Up to 24 months
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from study enrollment to the first documentation of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to 36 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from study enrollment to death from any cause.
Time frame: Up to 36 months
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.
Time frame: Up to 24 months
Recurrence-Free Survival (RFS)
Recurrence-free survival (RFS) is defined as the time from study enrollment (or surgery for applicable patients) to the first documentation of disease recurrence.
Time frame: Up to 36 months
Pathological Complete Response Rate (pCR)
Pathological complete response (pCR) is defined as the absence of residual tumor cells in the resected specimen after neoadjuvant or conversion therapy.
Time frame: At time of surgery (approximately within 6 months)
Safety and Tolerability
Incidence and severity of adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: Up to 36 months
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