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New combo therapy aims to keep stomach cancer from returning after surgery

NCT ID NCT07474324

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The First Affiliated Hospital with Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210000, China

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