Dynamic Circulating Tumor DNA Monitoring to Guide Systemic Therapy in Gastric Cancer

A Prospective Phase II Study of Dynamic Circulating Tumor DNA to Predict and Guide Systemic Treatment in Patients With Gastric Cancer

Dynamic Circulating Tumor DNA Monitoring to Guide Systemic Therapy in Gastric Cancer (NCT07517107) is a Phase 2 interventional studying Gastric Cancer, sponsored by Fudan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 600 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: \- Age ≥18 years. diagnosed by tissue sample (biopsy-confirmed) gastric or gastroesophageal junction adenocarcinoma. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. your organs (liver, kidneys, etc.) are working well enough based on blood tests within 7 days prior to enrollment, including: Absolute neutrophil count ≥1.5 × 10⁹/L Platelet count ≥80 × 10⁹/L blood count (hemoglobin) at least 80 g/L Total bilirubin ≤1.5 × upper limit of normal (ULN) AST and ALT ≤2.5 × ULN (≤5 × ULN in case of liver metastases) Serum creatinine ≤1.5 × ULN or kidney function (creatinine clearance) at least 60 mL/min Serum albumin ≥30 g/L Estimated life expectancy ≥3 months. Willingness to provide blood samples for circulating tumor DNA (ctDNA) analysis. Signed written willing to sign a consent form prior to any study-related procedures. Cohort-Specific Who May Qualify: Neoadjuvant/Conversion Cohort: 8\. Planned to receive neoadjuvant or conversion systemic therapy followed by potential surgery. 9\. Locally advanced (T3-T4a and/or N+, M0) or oligometastatic disease (≤1 metastatic organ and ≤5 lesions) considered potentially resectable after systemic therapy. 10\. No previous cancer treatment that works throughout the body (like chemotherapy) for gastric cancer. Adjuvant Cohort: 11\. Completion of curative-intent surgery for gastric cancer. 12. Pathological stage II-III disease without distant metastasis. 13. Planned to receive standard adjuvant chemotherapy (e.g., XELOX or SOX). Advanced Disease Cohort: 14\. Unresectable or metastatic disease not amenable to curative surgery. 15. Planned to receive systemic therapy, including chemotherapy with or without immunotherapy, as first-line or later-line treatment. 16\. At least one measurable lesion according to RECIST v1.1. Who Should NOT Join This Trial: \- ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: \- Age ≥18 years. 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 prior to enrollment, including: Absolute neutrophil count ≥1.5 × 10⁹/L Platelet count ≥80 × 10⁹/L Hemoglobin ≥80 g/L Total bilirubin ≤1.5 × upper limit of normal (ULN) AST and ALT ≤2.5 × ULN (≤5 × ULN in case of liver metastases) Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min Serum albumin ≥30 g/L Estimated life expectancy ≥3 months. Willingness to provide blood samples for circulating tumor DNA (ctDNA) analysis. Signed written informed consent prior to any study-related procedures. Cohort-Specific Inclusion Criteria: Neoadjuvant/Conversion Cohort: 8\. Planned to receive neoadjuvant or conversion systemic therapy followed by potential surgery. 9\. Locally advanced (T3-T4a and/or N+, M0) or oligometastatic disease (≤1 metastatic organ and ≤5 lesions) considered potentially resectable after systemic therapy. 10\. No prior systemic therapy for gastric cancer. Adjuvant Cohort: 11\. Completion of curative-intent surgery for gastric cancer. 12. Pathological stage II-III disease without distant metastasis. 13. Planned to receive standard adjuvant chemotherapy (e.g., XELOX or SOX). Advanced Disease Cohort: 14\. Unresectable or metastatic disease not amenable to curative surgery. 15. Planned to receive systemic therapy, including chemotherapy with or without immunotherapy, as first-line or later-line treatment. 16\. At least one measurable lesion according to RECIST v1.1. Exclusion Criteria: \- History of another malignancy within 5 years, except for 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 but not limited to: Unstable cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure) Severe infection Active disseminated intravascular coagulation Significant bleeding tendency Significant organ dysfunction that, in the investigator's judgment, would compromise patient safety. Symptomatic pleural effusion or ascites requiring intervention. Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.

Treatments Being Tested

DIAGNOSTIC_TEST

Circulating Tumor DNA (ctDNA) Analysis

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.

DRUG

Standard Systemic Therapy for Gastric Cancer

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer Center

Shanghai, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07517107), the sponsor (Fudan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07517107 clinical trial studying?

Who can participate in NCT07517107?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07517107?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07517107. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07517107. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.