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Chemotherapy
Chemotherapy + Immunotherapy for Esophageal and Gastric Cancer
Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
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 up to 3 years
Awards & highlights
Study Summary
This trial compares chemo drugs to treat advanced gastroesophageal cancer. Some get chemo plus immunotherapy drug to try to shrink tumor and extend life.
Who is the study for?
Adults with advanced, inoperable or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma can join. They shouldn't have had previous treatment for their advanced cancer but may have had prior therapy if completed over a year ago. Participants need adequate organ function and no active autoimmune diseases requiring recent treatment. Those with certain heart conditions or infections like HIV must meet specific criteria.Check my eligibility
What is being tested?
The trial compares mFOLFIRINOX (a combination of chemotherapy drugs) to mFOLFOX (another chemo combo), both aiming to stop tumor growth by killing cells or preventing cell division. Some patients will also receive Nivolumab, an immunotherapy drug designed to boost the immune system's response against cancer cells.See study design
What are the potential side effects?
Chemotherapy may cause nausea, fatigue, hair loss, increased risk of infection due to low blood counts, and nerve damage leading to numbness or tingling. Immunotherapy with Nivolumab might lead to immune-related side effects such as inflammation in various organs including the lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies), and skin rash.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Duration of Response
Overall response rate
Patient reported outcomes
+1 moreOther outcome measures
Exploratory correlative markers
Feasibility and compliance of intervention
Incidence of adverse events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (mFOLFIRINOX, nivolumab)Experimental Treatment9 Interventions
Patients receive fluorouracil IV, leucovorin calcium IV, oxaliplatin IV, and irinotecan IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.
Group II: Arm II (mFOLFOX, nivolumab)Active Control8 Interventions
Patients receive fluorouracil IV, leucovorin calcium IV, and oxaliplatin IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Nivolumab
2014
Completed Phase 3
~4750
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin Calcium
2011
Completed Phase 3
~12310
Computed Tomography
2017
Completed Phase 2
~2720
Fluorouracil
2014
Completed Phase 3
~11540
Irinotecan
2017
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,256 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,059 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am of childbearing age and have a negative pregnancy test.My cancer cannot be removed by surgery or has spread.I have never needed steroids for lung inflammation not caused by infection.I have never stopped immunotherapy permanently due to severe side effects.My liver function tests are within the required range.I do not have severe nerve damage.I do not have Gilbert's syndrome or a specific genetic condition.I have never needed steroids for a lung condition not caused by an infection.I have a heart condition that meets certain criteria.My cancer is in the esophagus, stomach, or where they meet.I am 18 years old or older.I haven't taken steroids or immunosuppressants in the last 14 days.I finished chemotherapy or immunotherapy for cancer more than a year ago.I have not had a transplant from another person.I am taking nivolumab and can safely use immune checkpoint inhibitors.I am fully active or restricted in physically strenuous activity but can do light work.I can speak, understand, and read in English, Spanish, Korean, Chinese, or Russian.I haven't needed treatment for an autoimmune disease in the last 6 months.I haven't received treatment for cancer that can't be removed or has spread.I have never stopped immunotherapy permanently due to severe side effects.I have another cancer that won't affect this treatment's safety or results.My kidney function, measured by creatinine levels or clearance, is within the required range.I do not have untreated brain tumors causing symptoms.My cancer is HER2 negative and has a known PD-L1 score.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (mFOLFIRINOX, nivolumab)
- Group 2: Arm II (mFOLFOX, nivolumab)
Awards:
This trial has 2 awards, including:- 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.
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.
What safety profile has been observed for the Arm I (mFOLFIRINOX, nivolumab) combination?
"Our assessment of Arm I (mFOLFIRINOX, nivolumab) safety is a 3 since there exist multiple data sets that validate the efficacy and safeguard measures associated with this Phase 3 trial."
Answered by AI
Is this experiment currently open to new participants?
"Yes, the clinical trial is still actively seeking participants. The date of first posting was January 23rd 2023 and the last update happened on July 10th 2023."
Answered by AI
How many participants are being monitored for this research endeavor?
"Affirmative. Evidenced by clinicaltrials.gov, this research project is actively searching for participants to enroll in the study. The initial post date was January 23rd 2023 and it has been amended most recently on July 10th 2023; 382 individuals are needed from a total of 496 sites across America."
Answered by AI
What is the current breadth of this medical study in our city?
"As of now, 496 individuals have enrolled in this trial from medical centres such as Anchorage Associates in Radiation Medicine, Anchorage Radiation Therapy Centre, and Alaska Breast Care and Surgery LLC. There are many more enrollees coming from other locations too."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Kaiser Permanente-Vallejo
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
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