Actively Recruiting
Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
Led by Canadian Cancer Trials Group · Updated on 2026-05-12
168
Participants Needed
18
Research Sites
141 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed HER2 positive gastroesophageal adenocarcinoma that is unresectable or metastatic
- Previous treatment with at least one trastuzumab-containing regimen plus platinum chemotherapy with disease progression
- Measurable or evaluable disease according to RECIST 1.1
- Suitable and able to receive paclitaxel and ramucirumab chemotherapy
- Consent to provide blood, serum, plasma, and tumor tissue samples
- Age 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Recent imaging (CT/MRI) within 28 days before randomization
- Adequate cardiac function with EF ≥ 50% within 4 to 8 weeks before randomization
- Adequate normal organ and marrow function
- Able and willing to complete quality of life questionnaires in English or French
- Consent obtained per local and regulatory requirements
- Accessible for treatment and follow-up with treatment starting within 2 working days of enrollment
- Use of highly effective contraception during and for 7 months after study treatment for those of childbearing potential
You will not qualify if you...
- History of other malignancies except certain treated cancers with no evidence of disease for at least 5 years
- Participation in another clinical study during this trial
- Active or uncontrolled illness
- HIV infection, active hepatitis B or positive hepatitis C antibody unless adequately controlled
- Any condition that would make protocol treatment dangerous or impair ability to receive therapy
- Psychological or geographical issues preventing protocol compliance
- Unresolved toxicity grade 2 or higher from previous anti-cancer therapy that increases risk during study treatment except irreversible toxicity not worsened by study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
2
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
3
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
4
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Actively Recruiting
5
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Actively Recruiting
6
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
7
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
8
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
9
London Health Sciences Centre Research Inc.
London, Ontario, Canada, N6A 5W9
Actively Recruiting
10
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
11
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Suspended
12
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
13
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
14
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
15
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
16
Centre Integre Universitaire De Sante Et De Services
Montreal, Quebec, Canada, H4J 1C5
Actively Recruiting
17
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
18
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
Research Team
C
Chris O'Callaghan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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