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New drug cocktail shows promise against aggressive stomach cancer

NCT ID NCT04661150

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 4 times

Summary

This study tests whether adding an immunotherapy drug (atezolizumab) to standard chemotherapy and targeted therapy (trastuzumab) can better shrink HER2-positive stomach or gastroesophageal junction cancer before surgery. About 42 adults with advanced but removable tumors will receive either the standard combo or the standard plus atezolizumab. The main goal is to see if the new combination leads to more complete tumor disappearance at the time of surgery.

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

42 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2026

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: * Histologically confirmed gastric cancer or adenocarcinoma of GEJ * HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by in situ hybridization (ISH) as assessed by local review based on pretreatment endoscopic biopsies. * Clinical stage at presentation: cT3/T4a/T4b, or N+, M0 as determined by AJCC staging system, 8th edition * Availability of pretreatment tumor specimen for biomarker analysis by central lab * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy \>= 12 weeks * Adequate hematologic and end-organ function * For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception during the treatment period and to continue its use for at least i) 5 months after the last dose of atezolizumab, ii) 7 months after the last dose of trastuzumab, or iii) 6 months after the last dose of capecitabine or oxaliplatin, whichever is longer. * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: * Stage IV (metastatic) or unresectable gastric/GEJ cancer determined by investigators * Prior systemic therapy for treatment of gastric cancer * History of malignancy other than GC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Cardiopulmonary dysfunction * Dyspnea at rest * Active or history of autoimmune disease or immune deficiency with the following exceptions: (a) Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid-replacement hormone are eligible for the study. (b) Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. (c) Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided allof following conditions are met: (i) Rash must cover \< 10% of body surface area (ii) Disease is well controlled at baseline and requires only low-potency topical corticosteroids (iii) No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Active tuberculosis * Patients with active hepatitis B * Patients with active hepatitis C

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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.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • First Hospital of China Medical University

    Shenyang, 110001, China

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Liaoning Provincial Cancer Hospital

    Shengyang, 110042, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjing, 300060, China

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

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