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New cocktail of drugs aims to fight advanced stomach cancer

NCT ID NCT07315750

Disease control Sponsor: RemeGen Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a combination of three drugs (disitamab vedotin, trastuzumab, and tislelizumab) works better than standard chemotherapy plus trastuzumab with or without pembrolizumab for people with advanced HER2-high stomach or gastroesophageal junction cancer. The study will enroll 555 participants who have not had prior treatment for advanced disease. The main goal is to see if the new combo delays cancer progression or improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Disitamab vedotin, trastuzumab, tislelizumab, CAPOX chemotherapy, pembrolizumab
What this could lead to
If this works, it could offer a more effective first-line treatment option for people with advanced HER2-high stomach cancer, potentially extending life without progression.
What could go wrong
This is an early-stage phase 3 trial with 555 participants, so results are not yet known. The new combination may not be better than standard therapy and could have more 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 555 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Voluntarily consent to participate in the study and sign the informed consent form * Expected survival period \>12 weeks * ECOG Performance Status 0 or 1 * Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma * No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy * HER2-high expression * At least one assessable lesion according to RECIST v1.1 criteria * Adequate organ function * Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment. * Able to understand the study requirements and willing to comply with the study and follow-up procedures Exclusion Criteria: * Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis * Peripheral neuropathy \> Grade 1 * Tumor lesions with a tendency to bleed * Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption * Bone metastases with a risk of paraplegia * Past or current interstitial lung disease, or severely impaired lung function * Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment * Pregnant or breastfeeding women

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Conditions

The condition(s) this trial relates to.

gastric carcinoma gastric neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric carcinoma

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

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, BJ-Beijing, 100021, China

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