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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through substudy completion, an average of 2 years
Awards & highlights
Study Summary
This trial tests new treatments for gastric/GEJ cancer to see if they're safe, effective and tolerable.
Who is the study for?
Adults over 18 with a body weight above 35 kg, diagnosed with advanced gastric or gastroesophageal junction adenocarcinoma that can't be surgically removed or has spread, and who haven't been treated for it yet. Participants should have a life expectancy of at least 12 weeks and good performance status (able to carry out daily activities). Those with active infections, previous immune-oncology treatments, certain HER2-positive cancers, uncontrolled brain metastases, serious illnesses, another cancer history or uncontrollable ascites are excluded.Check my eligibility
What is being tested?
The trial is testing new combinations of drugs including chemotherapy agents like 5-Fluorouracil and Capecitabine as well as novel therapies AZD0901, Rilvegostomig, FOLFOX regimen components and Volrustomig. It aims to evaluate how effective these combinations are in treating the cancer while also monitoring safety profiles and how the body processes the drugs.See study design
What are the potential side effects?
Potential side effects may include nausea and vomiting from chemotherapy; fatigue; allergic reactions; blood cell count changes leading to increased infection risk or bleeding problems; liver function alterations; diarrhea or constipation; mouth sores. Novel drug side effects vary but could involve similar issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through substudy completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through substudy completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR (per RECIST 1.1 as assessed by Investigator)
PFS6 (per RECIST 1.1 as assessed by Investigator)
Secondary outcome measures
DoR per RECIST 1.1 based on Investigator assessment.
OS
PFS per RECIST 1.1 as assessed by the Investigator
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Substudy 6Experimental Treatment4 Interventions
AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine
Group II: Substudy 5Experimental Treatment3 Interventions
AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Group III: Substudy 4Experimental Treatment4 Interventions
AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine
Group IV: Substudy 3Experimental Treatment4 Interventions
AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
Group V: Substudy 2Experimental Treatment3 Interventions
Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Group VI: Substudy 1Experimental Treatment3 Interventions
Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFOX
2009
Completed Phase 3
~4560
XELOX
2018
Completed Phase 3
~620
5-Fluorouracil
2012
Completed Phase 3
~7800
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,741 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My stomach cancer is HER2 positive or uncertain but not negative.I am 18 years old or older.My organs and bone marrow are working well.I have been treated with immunotherapy before.I do not have any uncontrolled illnesses.I am fully active or restricted in physically strenuous activity but can do light work.My ascites cannot be managed despite treatment.My cancer has spread to my brain or spinal cord and is either untreated or getting worse.I have not had treatments targeting Claudin18.2 or been exposed to MMAE.I do not have active infections like TB, HIV, or hepatitis B/C.I have not been treated for advanced stomach cancer.My body weight is over 35 kg.My tumor was tested and is Claudin18.2 positive from a recent or new biopsy.I have or had an autoimmune disease treated with steroids or other immune-suppressing drugs.I have had another type of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Substudy 2
- Group 2: Substudy 3
- Group 3: Substudy 6
- Group 4: Substudy 4
- Group 5: Substudy 5
- Group 6: Substudy 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is Substudy 2 hazardous to individuals?
"Based on the existing evidence, Substudy 2 received a score of 2. This is because it has progressed to Phase 2 and there is some data that suggests safety but not efficacy."
Answered by AI
Are there any available slots for the trial yet?
"As evidenced on clinicaltrials.gov, this particular trial is presently onboarding participants and was last updated March 15th of 2023 - with initial posting having taken place January 16th of the same year."
Answered by AI
How many healthcare facilities are currently participating in this experiment?
"At present, 26 medical sites are accepting participants for this clinical trial. These locations include Santander, Taoyuan City and Barcelona among many others; therefore it is highly beneficial to select the closest centre to reduce travel demands if one chooses to join the study."
Answered by AI
How many subjects are involved with this research endeavor?
"Affirmative. According to clinicaltrials.gov, this study is actively seeking participants with the first posting date of January 16th 2023 and last updated on March 15th 2023. 80 people are needed from 26 different medical centres for completion of the trial."
Answered by AI
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