Blood test may spare gastric cancer patients from unnecessary chemo
NCT ID NCT07257380
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a simple blood test that detects tiny traces of cancer DNA can guide treatment decisions after gastric cancer surgery. About 90 patients will have their blood tested after surgery, and those with no detectable cancer DNA may safely skip additional chemotherapy. The goal is to reduce side effects from unnecessary treatment without affecting how long patients stay cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- circulating tumor DNA (ctDNA) blood test
- What this could lead to
- If successful, this approach could spare many gastric cancer patients from unnecessary chemotherapy after surgery, reducing side effects while maintaining survival outcomes.
- What could go wrong
- This is a small, early-phase feasibility study (90 participants). The ctDNA test may not accurately predict who needs chemo, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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 to 79 years
- 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. Be able to provide a written informed consent form (ICF), and understand, agree to, and comply with the study requirements and assessment schedule. 2. Male or female aged 18 to 79 years. 3. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ), with clinical TNM staging (per the 8th edition of the AJCC/UICC Clinical TNM Staging for Gastric Cancer) as clinical Stage cIII to cIVa, and the primary gastric cancer lesion assessed to be amenable to curative resection. 4. ECOG PS ≤ 2, tolerable to surgical treatment, no surgical contraindications. 5. Females of childbearing potential must have a negative pregnancy test within 7 days prior to initiating neoadjuvant treatment. Males of reproductive potential and females of childbearing potential must agree to use adequate contraceptive measures during the study and for 24 months after the last dose of study medication. 6. Prior to neoadjuvant treatment, complete blood count (CBC) and biochemical tests must meet the following criteria: a) Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; b) Platelet Count (PLT) ≥ 75 × 10⁹/L; c) Hemoglobin (Hb) ≥ 80 g/L; d) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN); e) Serum Creatinine (Cr) ≤ 1.5 × ULN, or Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m²; f) Serum Albumin (ALB) ≥ 30 g/L; g) 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 value must be within the expected therapeutic range for the anticoagulant used. 7. No antitumor treatment for the tumor involved in the current study has been administered prior to the initiation of neoadjuvant treatment. Exclusion Criteria: 1. Subjects for whom investigators consider that there are obvious contraindications to (neo)adjuvant treatment or who cannot tolerate (neo)adjuvant treatment. 2. Females of childbearing potential who have not undergone surgical sterilization or do not use adequate contraceptive measures, pregnant or lactating females, and males who plan to impregnate their partners in the near term. 3. Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding, diabetes mellitus, and others. 4. Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral therapy, including but not limited to tuberculosis (TB), human immunodeficiency virus (HIV) infection, and others. 5. History of previous malignant tumors or other malignant tumors currently present, except for basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic/cervical/breast carcinoma in situ, and other such tumors that have been completely resected with no recurrence for at least 5 years. 6. Other circumstances that investigators deem inappropriate 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
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Other studies related to the condition(s) this trial covers.
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