Gastroesophageal AdenocarcinomaPhase 2NCT06043427
Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
A Phase 2 study testing Paclitaxel, Ramucirumab and Zanidatamab in people with Gastroesophageal Adenocarcinoma, run by Canadian Cancer Trials Group at 18 sites in Canada.
Trial summary
This study is being done to answer the following question: Can the chance of gastroesophageal cancer growing or spreading be lowered by adding a drug called zanidatamab to the usual combination of drugs? We are doing this study because we want to find out if this approach is better or worse than the usual approach for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Adenocarcinoma
- What is being tested?
- Paclitaxel, Ramucirumab and Zanidatamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 18 sitesCanada
- Study dates
- 16 Apr 2024to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Canada18 sites, 18 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Dawn Ng, 705 728-9090 ext. 43340
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Hatim Karachiwala
- Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Stephanie Snow, 902 473-3739
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Oren Levine, 905 387-9495 ext. 63123
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Brooke Wilson
- Recruiting
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, N2G 1G3
Anupam Batra
- Recruiting
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9
Daniel Breadner, 519 685-8600
- Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Moustapha Tehfe, 514 890-8000 ext. 25381
- Recruiting
Centre Integre Universitaire De Sante Et De Services
Montreal, Quebec, H4J 1C5
Setareh Samimi, 514 338-2150
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Amin Kay
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Rachel Goodwin, 613 737-8899 ext. 70185
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Muhammad Salim, 306 766-2691
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Adnan Zaidi, 306 655-2710
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Michael Raphael, 416 480-5000
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Suneil Khanna, 416 864-5734
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Elena Elimova, 416 946-4501 ext. 2520
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Howard Lim, 604 877-6000 ext. 672699
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
James T. Paul, 204 787-2108
About this study
Official title: A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma
This study is being done to answer the following question:
Can the chance of gastroesophageal cancer growing or spreading be lowered by adding a drug called zanidatamab to the usual combination of drugs?
We are doing this study because we want to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for gastroesophageal cancer
Read the detailed description
The purpose of this study is to compare the usual approach alone to using zanidatamab plus the usual approach. The addition of zanidatamab to the usual approach could shrink cancer. But, it could also cause side effects.
This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding zanidatamab to the usual approach reduces the risk of cancer getting worse by at least 37% compared to the usual approach.
- Conditions
- Gastroesophageal Adenocarcinoma
- Being tested
- Paclitaxel, Ramucirumab, Zanidatamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
80 mg/m²
RamucirumabDrug
8 mg/kg
ZanidatamabDrug
Dose and schedule to be assigned at enrollment
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel and Ramucriumab | Active comparator | Not described Receives: Drug: Paclitaxel; Drug: Ramucirumab |
| Zanidatamab + Paclitaxel and Ramucirumab | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Ramucirumab; Drug: Zanidatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 36 months
Secondary outcomes (5)
Overall survival
Measured: 36 months
Objective response rate
Measured: 36 months
Number and severity of adverse events
Measured: 36 months
Quality of Life utilizing the EORTC QLQ C30
Measured: 36 months
Quality of Life utilizing the EORTC QLQ-OES18
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start16 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Elena Elimova, Study chair, University Health Network, Princess Margaret Cancer Centre, Toronto ON Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043427
- Sponsor's protocol ID
- GA4
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06043427
- Acronym / sponsor ID
- GA4
- Conditions
- Gastroesophageal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Jazz Pharmaceuticals
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to answer the following question:
Can the chance of gastroesophageal cancer growing or spreading be lowered by adding a drug called zanidatamab to the usual combination of drugs?
We are doing this study because we want to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for gastroesophageal cancer
Detailed description
The purpose of this study is to compare the usual approach alone to using zanidatamab plus the usual approach. The addition of zanidatamab to the usual approach could shrink cancer. But, it could also cause side effects.
This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding zanidatamab to the usual approach reduces the risk of cancer getting worse by at least 37% compared to the usual approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel and Ramucriumab | Active comparator | Drug: Paclitaxel, Drug: Ramucirumab |
| Zanidatamab + Paclitaxel and Ramucirumab | Experimental | Drug: Paclitaxel, Drug: Ramucirumab, Drug: Zanidatamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel80 mg/m² | Drug | Paclitaxel and Ramucriumab, Zanidatamab + Paclitaxel and Ramucirumab |
| Ramucirumab8 mg/kg | Drug | Paclitaxel and Ramucriumab, Zanidatamab + Paclitaxel and Ramucirumab |
| ZanidatamabDose and schedule to be assigned at enrollment | Drug | Zanidatamab + Paclitaxel and Ramucirumab |
Primary outcome
Progression-free survival
Time frame: 36 months
5 secondary outcomes
Overall survival
Time frame: 36 months
Objective response rate
Time frame: 36 months
Number and severity of adverse events
Time frame: 36 months
Quality of Life utilizing the EORTC QLQ C30
Time frame: 36 months
Quality of Life utilizing the EORTC QLQ-OES18
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Elimova study chair
University Health Network, Princess Margaret Cancer Centre, Toronto ON Canada
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Ramucirumab and Zanidatamab in people with Gastroesophageal Adenocarcinoma, run by Canadian Cancer Trials Group at 18 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris O'Callaghan (613-533-6430, cocallaghan@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.