Actively Recruiting
Dynamic Circulating Tumor DNA Monitoring to Guide Systemic Therapy in Gastric Cancer
Led by Fudan University · Updated on 2026-04-08
600
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dynamic Circulating Tumor DNA Monitoring to Guide Systemic Therapy in Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate organ function within 7 days before enrollment, including specific blood counts and kidney and liver function
- Estimated life expectancy of at least 3 months
- Willingness to provide blood samples for ctDNA analysis
- Signed informed consent
- For Neoadjuvant/Conversion Cohort: planned neoadjuvant or conversion therapy followed by possible surgery; locally advanced or oligometastatic disease considered potentially resectable; no prior systemic therapy for gastric cancer
- For Adjuvant Cohort: completed curative surgery; pathological stage II-III without distant metastasis; planned standard adjuvant chemotherapy
- For Advanced Disease Cohort: unresectable or metastatic disease not suitable for surgery; planned systemic therapy including chemotherapy and/or immunotherapy; at least one measurable lesion per RECIST v1.1
You will not qualify if you...
- History of another malignancy within 5 years except adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer
- Uncontrolled central nervous system metastases or primary brain tumors
- Severe or uncontrolled comorbidities including unstable cardiovascular disease, severe infection, active disseminated intravascular coagulation, significant bleeding, or organ dysfunction compromising safety
- Symptomatic pleural effusion or ascites requiring intervention
- Any condition making patient unsuitable for study participation in investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
W
Weijian Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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