New combo therapy aims to keep stomach cancer from returning after surgery
NCT ID NCT07474324
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the targeted drug disitamab vedotin to standard chemotherapy (SOX) after surgery can help prevent stomach cancer from coming back in people with HER2-positive stage III disease. About 124 adults who had complete tumor removal with extensive lymph node removal will be randomly assigned to receive either the combination or chemotherapy alone. The main goal is to see if the combination improves the chance of being cancer-free three years later.
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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 124 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged between 18 and 75 years. * Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status. * No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery. * Histopathologically confirmed gastric adenocarcinoma. * Pathological stage III gastric and gastroesophageal junction adenocarcinoma patients (according to the 8th edition of the American Joint Committee on Cancer \[AJCC\] staging system). * HER2 moderate-to-high expression (IHC 3+ or 2+). * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. * Expected survival time ≥ 3 months. * Able to understand the study protocol, voluntarily participate in the study, and provide written informed consent; * Good compliance and able to cooperate with the treatment regimen specified in this study; * Possesses complete imaging and pathological clinical data; * Adequate organ and bone-marrow function. Exclusion Criteria: * Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed; * Unable to receive disitamab vedotin or SOX chemotherapy; * Unable to comply with the required follow-up schedule; * Unable to accept the treatment regimen specified in this protocol; * Unable or unwilling to undergo mandated response assessments (e.g., CT imaging); * Active autoimmune disease; * History of psychoactive-substance abuse that cannot be discontinued, or any severe/uncontrolled psychiatric disorder, or any severe/uncontrolled systemic disease; * Any concomitant condition that, in the investigator's opinion, poses significant risk to the subject or could compromise study completion; * Other malignancies within 5 years before screening, except adequately treated cancers considered cured (e.g., thyroid cancer, cervical carcinoma in situ, basal/squamous-cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery); * Lactating women; * Prior neoadjuvant therapy or intra-operative intraperitoneal chemotherapy.
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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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The First Affiliated Hospital with Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210000, China
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Other studies related to the condition(s) this trial covers.
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- New chemo combo could improve outcomes for stomach cancer patients