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New drug trio takes aim at HER2-Positive stomach cancer

NCT ID NCT06730373

Disease control Sponsor: Qilu Hospital of Shandong University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are comparing a new combination of disitamab vedotin, sintilimab, and S-1 against the standard regimen of trastuzumab plus chemotherapy, with or without sintilimab, for people with advanced HER2-positive gastric or gastroesophageal junction cancer. The trial enrolls about 110 adults who have not received prior systemic treatment for their advanced disease. The main goal is to see how many participants' tumors shrink or disappear with each approach.

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 plus sintilimab and S-1
What this could lead to
If the new combination works better than standard treatment, it could offer a new first-line option for people with advanced HER2-positive gastric cancer.
What could go wrong
This is a phase II trial with about 110 participants, so it cannot prove the combination is better than standard care. The drugs can cause nerve damage, immune reactions, and other side effects, and the results may not apply to everyone.

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 110 people

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

Started

Oct 2024

Expected to finish

Dec 2027

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: 1. Aged18-80 years, gender is not limited; 2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis; 3. HER2-Positive (IHC3+or IHC2+/FISH+) ; 4. Has at least 1 measurable lesion as determined by RECIST 1.1; 5. There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Adequate organ function; 8. The life expectancy is at least 3 months; Exclusion Criteria: 1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug; 2. Cardiovascular and cerebrovascular events that are not well controlled; 3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks. 4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.); 5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases; 6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment; 7. Brain metastasis or leptomeningeal metastasis; 8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug; 9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ); 10. Any major surgery was performed ≤ 28 days before the first trial drug administration; 11. History of allogeneic stem cell transplantation or organ transplantation;

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric carcinoma gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

HER2-positive gastric cancer Metastatic gastric cancer Unresectable 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

    20 sites. 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

  • Affiliated Hospital of Jining Medical College

    RECRUITING

    Jining, Shandong, China

  • Binzhou Medical University Hospital

    NOT_YET_RECRUITING

    Binzhou, Shandong, China

  • Jinan Third People's Hospital

    RECRUITING

    Jinan, Shandong, China

  • Liaocheng People's Hospital

    RECRUITING

    Liaocheng, Shandong, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, China

  • Qilu Hospital of Shandong University(Qingdao)

    RECRUITING

    Qingdao, Shandong, 250063, China

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shandong Provincial Third Hospital

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shandong Univerisity Qilu Hospital

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shengli Oilfield Central Hospital

    RECRUITING

    Dongying, Shandong, China

  • Taian City Central Hospital

    NOT_YET_RECRUITING

    Taian, Shandong, China

  • Tengzhou Central People's Hospital

    RECRUITING

    Tengzhou, Shandong, 277599, China

  • The Affiliated Hospital of Qingdao University

    NOT_YET_RECRUITING

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The Second Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Taian, Shandong, China

  • Weifang Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Weifang, Shandong, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, China

  • Yantaishan Hospital

    RECRUITING

    Yantai, Shandong, China

  • Zibo Central Hospital

    RECRUITING

    Zibo, Shandong, China

  • Zibo First People's Hospital

    RECRUITING

    Zibo, Shandong, China

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