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Zanidatamab + Chemotherapy for Gastrointestinal Cancers
Study Summary
This trial is testing a new cancer drug, zanidatamab, to see if it is safe and effective for treating certain types of gastrointestinal cancers. Eligible patients have cancer that has spread and cannot be removed by surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have been treated with a HER2-targeted therapy before.My condition meets the criteria outlined in Part 1.My bile duct cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.I haven't had cancer treatment recently, except for early-stage therapy over 6 months ago.I have treated brain metastases and have been stable without steroids or seizure meds for 1 month.My heart's left ventricle is functioning well.My stomach cancer is advanced or has spread and tests show it is HER2 positive.My colorectal cancer is advanced, cannot be surgically removed, and tests positive for HER2 without certain gene mutations.My nerve damage does not severely affect my daily activities.My stomach cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.I do not have serious heart conditions or recent heart attacks.I do not have any health conditions that prevent me from taking bevacizumab.I don't have another cancer that could affect this treatment's safety or results.My organs are working well.I have colorectal cancer and have had only one cycle of 5-FU-based chemotherapy.I have started treatment for advanced bile tract cancer but haven't completed more than one cycle of gemcitabine-based chemotherapy.I finished palliative radiotherapy at least 2 weeks ago.I have been diagnosed with a specific disease.I have a serious lung condition affecting the tissue and space around the air sacs.I do not have active hepatitis B or C, or if I have HIV, it is well controlled.This information is part of a larger set of criteria.This information is part of a multi-step process.My cancer can be measured or observed.I am fully active or can carry out light work.
- Group 1: ZW25 + mFOLFOX6 with bevacizumab
- Group 2: ZW25 + FP
- Group 3: ZW25 + CisGem
- Group 4: ZW25 + mFOLFOX6
- Group 5: ZW25 + XELOX
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What risks have been associated with the use of Zanidatamab (ZW25)?
"There is some evidence suggesting ZW25 (Zanidatamab) may be safe, so it was allocated a rating of 2. However, since this Phase 2 trial there are no available data that point to the drug's efficacy."
Is there precedent for medical research involving Zanidatamab (ZW25)?
"Currently, 1771 clinical trials are evaluating the efficacy of ZW25 (Zanidatamab). Of those studies, 563 have reached Phase 3. In all 81965 medical centres across Guangzhou, Guangdong are running these tests."
Is enrollment open to participants for this research?
"Affirmative. Clinicaltrials.gov's records demonstrate that this medical trial, which began recruiting on August 29th 2019, is still searching for participants to enroll in the study. 362 individuals need to be enrolled across 8 centres nationwide."
What is the cap for enlistment in this medical experiment?
"This clinical study requires 362 suitable patients to be enrolled. Zymeworks Inc., is managing the protocol from Omaha's Nebraska Methodist Hospital and USC/Norris Comprehensive Cancer Center in LA, California."
How many facilities are involved in conducting this research experiment?
"This study is conducted in 11 sites, including Nebraska Methodist Hospital (Omaha), USC/Norris Comprehensive Cancer Center (Los Angeles), and Cancer and Hematology Centers of Western Michigan (Kalamazoo) as well as 8 additional locations."
What medical indications is Zanidatamab (ZW25) commonly employed to treat?
"Zanidatamab (ZW25) is the drug of choice for treating urinary bladder cancer, as well as advanced testicular carcinoma, refractory fallopian tube malignancy and small cell lung neoplasia."
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