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Zanidatamab + Chemotherapy ± Tislelizumab for Stomach and Esophageal Cancer (HERIZON-GEA-01 Trial)
HERIZON-GEA-01 Trial Summary
This trial will test whether zanidatamab, when given with chemotherapy, is more effective than trastuzumab given with chemotherapy.
HERIZON-GEA-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHERIZON-GEA-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HERIZON-GEA-01 Trial Design
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Who is running the clinical trial?
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- I am fully active or restricted in physically strenuous activity but can do light work.I have had chemotherapy for advanced stomach or esophagus cancer that couldn't be removed by surgery.I have a history of or currently have leptomeningeal disease.I do not have serious heart conditions like uncontrolled high blood pressure or heart failure.I have been treated with drugs targeting immune checkpoints.My cancer is advanced stomach or esophagus cancer that cannot be removed by surgery and tests positive for HER2.I had COVID-19 but have recovered according to my local health guidelines.I have a history of HIV infection.I have not had HER2 treatment for GEA, except if it was for breast cancer over 5 years ago.I have active hepatitis.My organs are working well.I have another cancer that is not cured or was treated in the last 3 years.I have brain metastases but haven't received treatment for them in the last 4 weeks.
- Group 1: Arm C
- Group 2: Arm B
- Group 3: Arm A
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this a trial that is still recruiting participants?
"That is correct. The clinicaltrials.gov website shows that this trial, which was originally advertised on December 2nd 2021, is still looking for participants. In total, they need 714 patients from 2 different trial sites."
What are the traditional indications for Zanidatamab?
"Zanidatamab is an effective treatment for duke's c colon cancer as well as other forms of cancer like neoplasm metastasis, inflammatory breast cancer (ibc), and advanced testicular cancer."
Are there other case studies that feature Zanidatamab?
"Zanidatamab is being studied in 528 Phase 3 clinical trials, 1585 of which are currently active. While the majority of research is based in Seattle, Washington, there are over 77 thousand research sites around the world."
Has Zanidatamab been cleared by the FDA for general use?
"There is some evidence from efficacy data in clinical trials as well as data from multiple rounds of safety testing that suggests Zanidatamab is safe for use. We rate it a 3 on our Power scale."
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