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New drug duo aims to halt stomach cancer spread

NCT ID NCT06043427

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 2 times

Summary

This study tests whether adding a drug called zanidatamab to the usual chemotherapy can slow or stop the growth of advanced stomach, esophagus, or gastroesophageal junction cancer that is HER2-positive. About 168 adults who have already tried one standard treatment will be randomly assigned to receive either the usual drugs alone or with zanidatamab. The goal is to see if the new combination helps people live longer without their cancer getting worse.

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 168 people

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

Started

Apr 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Participants must have histologically or pathologically confirmed gastroesophageal adenocarcinoma (stomach, gastroesophageal junction or esophagus) that is unresectable or metastatic and which must be HER2 positive as confirmed by central testing using FDA-approved HER2 assay. HER2 positive is defined as IHC 3+, or IHC 2+ and FISH positive. * Participants must have received and failed at least one prior trastuzumab-containing regimen in combination with platinum-based chemotherapy for treatment of locally advanced or metastatic disease. Failure is defined as demonstrated objective disease progression (radiologic) on the most recently administered HER2 targeting agent. * Participants must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). * Participants must be considered a suitable candidate for, and able to receive chemotherapy for advanced disease with paclitaxel and ramucirumab. * Participants must consent to the provision of samples of blood, serum and plasma in order that the specific correlative marker assays may be conducted. * Participants must consent to provision of, and investigator(s) must confirm access to a representative formalin fixed paraffin embedded (FFPE) block of tumour tissue/ or a predetermined number of freshly cut slides of representative tumour tissue of adequate amount and quality in order that the central HER2 testing may be done * Participants must be ≥ 18 years of age. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must have a life expectancy of at least 12 weeks at the time of study entry * Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be done within 28 days prior to randomization * Participants must have adequate cardiac function by ECHO or MUGA defined as EF ≥ 50%. This is to be performed within 4 weeks (preferred) but no more than 8 weeks prior to randomization * Participants must have adequate normal organ and marrow function * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French * Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. * Participant must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment * Participants of childbearing potential must have agreed to use a highly effective contraceptive method for the entire period of study treatment and for at least 7 months after discontinuing study therapy. Exclusion Criteria: * Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Patients with a history of other malignancies detected at an early stage and whom the investigator believes have been curatively treated and are at a low risk of recurrence MAY be eligible * Participants receiving therapy in a concurrent clinical study. Patients must agree not to participate in other clinical studies during their participation in this trial while on study treatment * Participants with active or uncontrolled intercurrent illness * Participants with human immunodeficiency virus infection (positive HIV 1/2 antibodies), active hepatitis B infection (positive HBV surface antigen (HBsAg)) or positive for hepatitis C (HCV) antibody may be considered for enrollment, if infection is adequately controlled in the opinion of the investigator. * Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy * Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol * Any unresolved toxicity (CTCAE grade 2 or greater) from previous anti-cancer therapy which in the opinion of the investigator puts the participant at higher than expected risk during protocol treatment. However, participants with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational products in the Investigator's opinion may be included.

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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

    18 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

  • Allan Blair Cancer Centre

    RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

  • Arthur J.E. Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • BCCA - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Centre Integre Universitaire De Sante Et De Services

    RECRUITING

    Montreal, Quebec, H4J 1C5, Canada

  • Juravinski Cancer Centre at Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Kingston Health Sciences Centre

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Lakeridge Health Oshawa

    RECRUITING

    Oshawa, Ontario, L1G 2B9, Canada

  • London Health Sciences Centre Research Inc.

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Odette Cancer Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • QEII Health Sciences Centre

    RECRUITING

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Royal Victoria Regional Health Centre

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Saskatoon Cancer Centre

    RECRUITING

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Waterloo Regional Health Network (WRHN)

    RECRUITING

    Kitchener, Ontario, N2G 1G3, Canada

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