Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06043427

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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