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Chemotherapy + Immunotherapy for Stomach Cancer
Phase 2
Waitlist Available
Led By Weijing Sun, MD, FACP
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male/female participants who are 18 - 75 years of age with histologically or cytologically confirmed diagnosis of adenocarcinoma of the gastroesophegeal junction (GEJ) or stomach
Have newly diagnosed localized or locally advanced, potentially resectable disease without any prior systemic chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to see if they are effective and safe in treating stomach cancer.
Who is the study for?
This trial is for adults aged 18-75 with newly diagnosed, potentially operable stomach or gastroesophageal junction cancer without distant spread. Participants must be fit for surgery, have no recent other cancers or major illnesses, and not be pregnant or breastfeeding. They should agree to use contraception and provide tissue samples.Check my eligibility
What is being tested?
The study tests the combination of mFOLFOX6 chemotherapy with Pembrolizumab (an immunotherapy drug) before and after surgery in patients with stomach or GEJ cancer. The goal is to assess how well this combo works against the tumor and its safety.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive issues like nausea and diarrhea, blood cell count changes increasing infection risk, skin reactions, and potential nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old with a confirmed diagnosis of stomach or GEJ cancer.
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My cancer is new, localized or locally advanced, and I haven't had chemotherapy.
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I am a woman who can have children and have a negative pregnancy test.
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I have a tumor that can be measured and tissue from before surgery is available.
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I am willing to undergo a biopsy for my cancer study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has not spread to distant parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events related to toxicity.
Pathological response rate (ypRR)
Secondary outcome measures
Disease Free Survivial (DFS)
Objective response rate (ORR)
Overall Survival (OS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: mFOLFOX6 (Leucovorin-Fluorouracil-Oxaliplatin) + PembrolizumabExperimental Treatment2 Interventions
Drug: Pembrolizumab Dose: 200 mg Dose Frequency: Every three weeks (Q3W) Route: Intravenous (IV) infusion
Drug: Oxaliplatin Dose: 85 milligrams per meter squared (mg/m2) Dose Frequency: Every 2 weeks (Q2W) Route: IV infusion
Drug: Leucovorin Dose: 400 mg/m2 Dose Frequency: Q2W Route: IV infusion
Drug: Fluorouracil Dose: 400 mg/m2 Dose Frequency: Q2W Route: IV bolus
Drug: Fluorouracil Dose: 2,400 mg/m2 Dose Frequency: Q2W Route: IV continuous 46-hour infusion
Pembrolizumab will be administered at a fixed dose of 200 mg IV over 30 minutes every 3 weeks. Participants will receive 3 doses of the drug on Days 1, 22, 43 during the neoadjuvant phase of the study, and 12 doses of the drug on Days 1, 22, 43 during the adjuvant phase of the study (total 15 doses). Participants will receive 4 doses of mFOLFOX6 regimen on Days 1, 15, 29, 43 during the neoadjuvant phase of the study, and 4 doses during the adjuvant phase of the study (total 8 doses).
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,117 Total Patients Enrolled
5 Trials studying Adenocarcinoma
95 Patients Enrolled for Adenocarcinoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,513 Total Patients Enrolled
50 Trials studying Adenocarcinoma
8,982 Patients Enrolled for Adenocarcinoma
Weijing Sun, MD, FACPPrincipal InvestigatorThe University of Kansas - Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old with a confirmed diagnosis of stomach or GEJ cancer.My cancer is new, localized or locally advanced, and I haven't had chemotherapy.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I am a woman who can have children and have a negative pregnancy test.I am not pregnant or breastfeeding and will follow birth control advice for 4 months after treatment.I have a tumor that can be measured and tissue from before surgery is available.I am willing to undergo a biopsy for my cancer study.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of HIV, Hepatitis B, or active Hepatitis C.I cannot have surgery due to other health issues.I have an immune system disorder or have been on steroids recently.I had chemotherapy, radiation, or surgery for esophagus/stomach cancer within the last 4 weeks.I am currently being treated for an infection.I don't have any health conditions that would stop me from taking the study drugs.I have an active tuberculosis infection.I don't have any health issues that could affect the study's results.I am not pregnant, as confirmed by a test within the last 72 hours.I have been treated with specific immune therapy drugs before.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I had radiotherapy less than 2 weeks before starting the study treatment.My cancer has spread to my windpipe area or caused a hole between my windpipe and esophagus.I have not received a live vaccine in the last 30 days.I have another cancer that is getting worse or was treated in the last 3 years.I have had pneumonitis treated with steroids or currently have it.I have an autoimmune disease that needed treatment in the last 3 months.My organs are functioning well.My cancer has not spread to distant parts of my body.My cancer has spread to distant parts of my body.I am fit and eligible for surgery aimed at curing my condition.
Research Study Groups:
This trial has the following groups:- Group 1: mFOLFOX6 (Leucovorin-Fluorouracil-Oxaliplatin) + Pembrolizumab
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.
Are there other research papers which mention using Adjuvant Treatment - mFOLFOX & Pembrolizumab together?
"There are currently 1000 clinical trials underway studying Adjuvant Treatment - mFOLFOX & Pembrolizumab. 122 of those studies are in Phase 3. While the majority of trials for Adjuvant Treatment - mFOLFOX & Pembrolizumab are based in Houston, Texas, there are 36030 locations running studies for this treatment worldwide."
Answered by AI
How many people have signed up to participate in this experiment?
"Yes, that is correct. The listing on clinicaltrials.gov suggests that this particular study is still recruiting patients. This trial was first posted on 6/27/2018 and updated as recently as 5/17/2022. At the moment, the plan is to enroll 40 individuals at a single site."
Answered by AI
What was the outcome of the research surrounding adjuvant treatment with mFOLFOX and Pembrolizumab?
"Adjuvant Treatment - mFOLFOX & Pembrolizumab has some data supporting safety, but none for efficacy, giving it a score of 2."
Answered by AI
Are new patients being enrolled in this trial at this time?
"The clinicaltrials.gov website shows that this trial is currently looking for patients; the listing was originally made on 6/27/2018 and was last updated on 5/17/2022."
Answered by AI
What is the hope for this experiment?
"This clinical trial will last for up to 14 months and its primary goal is to Pathological response rate (ypRR). The study will also assess secondary objectives including Overall Survival (OS), Programmed cell death ligand 1 (PD-L1) expression in tumor cells, and Objective response rate (ORR). Participants will be evaluated at baseline and reevaluated 2-4 weeks after surgery."
Answered by AI
Are mature adults welcome in this clinical trial?
"In order for an individual to be eligible for this clinical trial, they must be between 18-75 years old."
Answered by AI
What is the primary purpose of adjuvant therapy with mFOLFOX & pembrolizumab?
"Adjuvant Treatment - mFOLFOX & Pembrolizumab is most often used to treat malignant neoplasms; however, it can also be an effective form of treatment for microsatellite instability high, unresectable melanoma, and disease progression after chemotherapy."
Answered by AI
How can I sign up to be a part of this research?
"The age limit for this adenocarcinoma clinical trial is 75 years old and the minimum age requirement is 18. Out of the 40 total participants, how many will be chosen remains to be seen."
Answered by AI
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