Blood test could spare stomach cancer patients from unnecessary chemo
NCT ID NCT07508956
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a simple blood test that detects tiny bits of tumor DNA (ctDNA) can help doctors decide which stomach cancer patients need extra chemotherapy after surgery. About 304 people with locally advanced stomach cancer will be randomly assigned to either standard care or treatment guided by the blood test. The goal is to see if this approach can reduce unnecessary treatments and side effects while keeping survival rates just as good.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 304 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to provide written informed consent (ICF) and capable of understanding and agreeing to comply with the study requirements and assessment schedule; 2. Male or female aged ≥ 18 years; 3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, with clinical TNM stage (according to the 8th edition of the AJCC/UICC clinical TNM staging system for gastric cancer; see Appendix 1) of cIIB-IVA, and the primary gastric tumor assessed as amenable to radical resection; 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2), fit to undergo surgical treatment with no contraindications to surgery; 5. Capable of providing adequate tumor tissue obtained via gastroscopy (or other means) prior to neoadjuvant treatment for whole-exome sequencing; 6. Females of childbearing potential must have a negative pregnancy test within 7 days before initiation of neoadjuvant treatment. Males and females of childbearing potential must agree to use adequate contraception during the study period and for 24 months after the last dose of study treatment (see Appendix 3); 7. Hematologic and biochemical parameters meeting the following criteria prior to neoadjuvant treatment: * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L * Platelet count (PLT) ≥ 75 × 10⁹/L * Hemoglobin (Hb) ≥ 80 g/L * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) * Serum creatinine (Cr) ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m² * Serum albumin (ALB) ≥ 30 g/L * For subjects not receiving anticoagulant therapy: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; for subjects receiving anticoagulant therapy: PT within the expected therapeutic range for the anticoagulant; 8. No prior anticancer therapy for the current study-related tumor prior to initiation of neoadjuvant treatment. Exclusion Criteria: 1. Patients deemed by the investigator to have significant contraindications to or intolerance of neoadjuvant/adjuvant therapy; 2. Female patients of childbearing potential who have not undergone surgical sterilization or are not using adequate contraceptive measures, pregnant or lactating women, or male patients planning to father a child within a short period; 3. Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active hemorrhage, diabetes mellitus, etc.; 4. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis, human immunodeficiency virus (HIV) infection, etc.; 5. Prior history of malignancy or current presence of another malignancy, except for completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast with at least 5 years without recurrence; 6. Other conditions deemed by the investigator to render the patient unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood test guides immunotherapy for hidden cancer cells