Actively Recruiting
A Randomized Phase II Study of Paclitaxel and Ramucirumab With or Without Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma
Led by Canadian Cancer Trials Group · Updated on 2026-05-12
168
Participants Needed
18
Research Sites
26 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
Researchers are evaluating whether adding the drug zanidatamab to the usual drug combination of paclitaxel and ramucirumab can reduce the chance of gastroesophageal adenocarcinoma growing or spreading. This study focuses on patients with HER2 positive advanced gastroesophageal cancer who have already received prior treatment with trastuzumab-based chemotherapy. The goal is to find out if this new approach is better than the standard treatment for this cancer type. Participants will be randomly assigned to receive either the usual treatment of paclitaxel and ramucirumab or the same treatment plus zanidatamab. Paclitaxel is given at a dose of 80 mg/m2 and ramucirumab at 8 mg/kg, while zanidatamab dosing will be assigned at enrollment. The study aims to compare these two approaches over a treatment period to observe any differences in cancer progression and side effects. During the study, participants will have imaging scans such as CT or MRI to assess disease status, and heart function tests (ECHO or MUGA) before starting treatment. Blood and tissue samples will be collected for marker testing. Researchers will monitor progression-free survival over 36 months as the main outcome, along with overall survival, response rates, adverse events, and quality of life assessments using specific questionnaires. Participants will be followed closely for treatment effects and safety throughout the study duration.
CONDITIONS
Brief Title
Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed HER2 positive gastroesophageal adenocarcinoma that is unresectable or metastatic
- Participants must have failed at least one prior trastuzumab-containing regimen with platinum-based chemotherapy
- Participants must have measurable or evaluable disease by RECIST 1.1 criteria
- Participants must be suitable for and able to receive chemotherapy with paclitaxel and ramucirumab
- Participants must consent to provide blood, serum, plasma, and tumor tissue samples for testing
- Participants must be 18 years or older
- Participants must have ECOG performance status of 0 or 1
- Participants must have a life expectancy of at least 12 weeks
- Imaging scans to document disease must be done within 28 days prior to randomization
- Participants must have adequate heart function (ejection fraction ≥ 50%) within 4 to 8 weeks before randomization
- Participants must have adequate normal organ and marrow function
- Participants must be able and willing to complete quality of life questionnaires in English or French
- Participants must provide informed consent per local regulations
- Participants must be accessible for treatment and follow-up
- Treatment should begin within 2 working days of enrollment
- Participants of childbearing potential must use effective contraception during treatment and for 7 months after stopping therapy
You will not qualify if you...
- Participants with history of other malignancies except certain treated skin cancers or in-situ cervical cancer, or other tumors treated with no disease for 5 or more years
- Participants currently enrolled in other clinical studies
- Participants with active or uncontrolled illnesses
- Participants with uncontrolled HIV, active hepatitis B, or hepatitis C unless adequately controlled
- Participants with any condition making study treatment unsafe or compliance difficult
- Participants with unresolved moderate or severe toxicity from prior cancer therapy unless judged safe by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or unacceptable side effects
Participants receive paclitaxel and ramucirumab, with or without zanidatamab, to treat HER2 positive advanced gastroesophageal adenocarcinoma.
Weekly visits for treatment and monitoring
Duration - Up to 36 months
Participants are monitored for cancer progression, survival, side effects, and quality of life after treatment ends.
Regular visits during follow-up period
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
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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