Recruiting
Phase 2

Paclitaxel & Ramucirumab

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06043427

Conditions

Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paclitaxel

Ramucirumab

Zanidatamab

Study Details

Brief 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 this type of cancer. The usual approach is defined as care most people get for gastroesophageal cancer

Conditions

Gastroesophageal Adenocarcinoma

Study ID

NCT06043427

Start date

Apr 16, 2024

Status verified date

Jan, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Paclitaxel and Ramucriumab

experimental: Zanidatamab + Paclitaxel and Ramucirumab

Interventions

Paclitaxel

80 mg/m²

Ramucirumab

8 mg/kg

Zanidatamab

Dose and schedule to be assigned at enrollment

Primary outcome measure

  • Progression-free survival [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Chris O'Callaghan

613-533-6430cocallaghan@ctg.queensu.ca

Locations

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Howard Lim

604 877-6000

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

James T. Paul

204 787-2108

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

Stephanie Snow

902 473-3739

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Dawn Ng

705 728-9090

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Oren Levine

905 387-9495

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Waterloo Regional Health Network (WRHN)

Recruiting

Kitchener, Ontario, Canada, N2G 1G3

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Daniel Breadner

519 685-8600

Lakeridge Health Oshawa

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Rachel Goodwin

613 737-8899

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Michael Raphael

416 480-5000

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Suneil Khanna

416 864-5734

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Elena Elimova

416 946-4501

CHUM-Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Moustapha Tehfe

514 890-8000

Centre Integre Universitaire De Sante Et De Services

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

Setareh Samimi

514 338-2150

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Muhammad Salim

306 766-2691

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Adnan Zaidi

306 655-2710

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Aug 11, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-08-11.