New Three-Drug cocktail aims to wipe out stomach cancer before surgery
NCT ID NCT07658872
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the targeted drug fruquintinib to standard immunotherapy (sintilimab) and chemotherapy (SOX) can improve outcomes for people with locally advanced stomach or gastroesophageal junction cancer. About 120 participants will receive either the three-drug combo or the standard two-drug regimen before and after surgery. The main goal is to see if the new combination leads to a higher rate of complete tumor disappearance at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fruquintinib (a targeted cancer drug), sintilimab (an immunotherapy), and SOX chemotherapy (S-1 and oxaliplatin)
- What this could lead to
- If successful, this combination could become a new treatment option before and after surgery for locally advanced stomach cancer, potentially improving the chance of complete tumor disappearance.
- What could go wrong
- This is an early phase 2 trial with only 120 people, so results may not apply to everyone. Adding more drugs also increases the risk of side effects.
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 120 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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Apr 2028
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 75 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. Age 18-75 years. 2. Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Clinically staged as T3-4a N0-3M0 by computed tomography (CT) or magnetic resonance imaging (MRI). 5. Considered eligible for curative resection. 6. No prior antitumor therapy for the current disease. 7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria. 8. Expected survival of ≥6 months. Exclusion Criteria: 1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor. 2. Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled. 3. Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator. 4. History of thromboembolic or arterial/venous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism. 5. Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.
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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 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.
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Other studies related to the condition(s) this trial covers.
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