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Chemotherapy
Pembrolizumab + Chemo/Radiation for Gastric Cancer
Phase 1 & 2
Waitlist Available
Led By Harry H. Yoon, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgically resectable (T2N0, T3N0, Tany with node positivity, M0), as determined by endoscopic ultrasound (EUS) and specific diagnostic work-up
Tumor is amenable to standard resection and reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the date of study registration to the date of death due to all causes, recurrences if r0 resections are achieved, progression disease before undergoing surgery, or r1/r2 resection at surgery, whichever comes first, assessed up to 3 years
Awards & highlights
Study Summary
This trial is studying how well pembrolizumab works with combination chemotherapy and radiation therapy before surgery in treating patients with gastroesophageal junction or gastric cardia cancer.
Who is the study for?
Adults with gastroesophageal junction or gastric cardia cancer that can be surgically removed may join. They must have confirmed adenocarcinoma, no distant metastases, acceptable organ function and nutritional status, and an ECOG performance status of 0 or 1. Women should use birth control; men too. Exclusions include prior treatments for the malignancy, active autoimmune disorders, uncontrolled diabetes, severe heart or lung conditions, a BMI over 35, certain infections or illnesses.Check my eligibility
What is being tested?
The trial is testing pembrolizumab (a monoclonal antibody) combined with chemotherapy drugs like carboplatin and paclitaxel plus radiation therapy before surgery to see if it's effective in shrinking tumors in gastroesophageal junction or gastric cardia cancer patients who are candidates for surgery.See study design
What are the potential side effects?
Possible side effects include allergic reactions to treatment components (like Cremophor), immune system complications due to pembrolizumab potentially affecting healthy cells while targeting tumor cells, typical chemotherapy-related issues such as nausea and hair loss, and radiation-induced skin changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at a stage where surgery can remove it, according to specific tests.
Select...
My tumor can be surgically removed and the area reconstructed.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I agree to use contraception.
Select...
My cancer is confirmed to be in the upper part of my stomach or where my esophagus meets my stomach.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the date of study registration to the date of death due to all causes, recurrences if r0 resections are achieved, progression disease before undergoing surgery, or r1/r2 resection at surgery, whichever comes first, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the date of study registration to the date of death due to all causes, recurrences if r0 resections are achieved, progression disease before undergoing surgery, or r1/r2 resection at surgery, whichever comes first, assessed 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
Pathological Complete Response (PathCR) Rate
Secondary outcome measures
Neoplasms
Disease-free Survival (DFS)
Incidence of Dose-limiting Toxicities (DLTs) Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, chemotherapy, radiation, surgery)Experimental Treatment11 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Computed Tomography
2017
Completed Phase 2
~2720
Leucovorin Calcium
2011
Completed Phase 3
~12310
Paclitaxel
2011
Completed Phase 4
~5380
Positron Emission Tomography
2008
Completed Phase 2
~2210
Fluorouracil
2014
Completed Phase 3
~11540
Pembrolizumab
2017
Completed Phase 2
~2010
Radiation Therapy
2017
Completed Phase 3
~7250
Oxaliplatin
2011
Completed Phase 4
~2560
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,233 Previous Clinical Trials
3,771,801 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,704 Previous Clinical Trials
40,931,419 Total Patients Enrolled
Harry H. Yoon, M.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and I agree to use birth control during the study due to risks of birth defects.I had a PET scan within the last 28 days showing no distant cancer spread.I have a specific heart condition.I have a lung condition.I do not have any uncontrolled illnesses.My cancer is at a stage where surgery can remove it, according to specific tests.My tumor can be surgically removed and the area reconstructed.I have consulted with specialists in surgery, radiation, and medical oncology.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use contraception.I have not had any other cancer within the last 5 years.I have dementia or changes in my mental status.I do not have severe nerve damage symptoms.I do not have any serious infections or medical conditions.I have received treatment for my cancer before.My organs are working well.My cancer is confirmed to be in the upper part of my stomach or where my esophagus meets my stomach.I can eat well, am well-nourished, and my lungs work properly.My tumor does not meet the specific criteria mentioned.I am following the required birth control measures.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, chemotherapy, radiation, surgery)
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.
What are some other ways Pembrolizumab has been studied in the past?
"Pembrolizumab was first studied in 1997 at City of Hope Comprehensive Cancer Center. Since then, there have been a total of 3418 completed clinical trials. Additionally, there are 2529 active clinical trials taking place across the world right now; many of these parellel studies are based out of Phoenix, Arizona."
Answered by AI
Are recruitment efforts still underway for this particular clinical trial?
"Unfortunately, this particular clinical trial is not recruiting patients at the moment. According to the information available on clinicaltrials.gov, which was last edited on August 3rd, 2022, recruitment for this study has wrapped up. Although this may be disappointing news, it's worth noting that there are 3740 other trials actively looking for participants right now."
Answered by AI
How can I get involved in this research project?
"Eligibility for this clinical trial is restricted to patients that have stage ii gastric cancer ajcc v7 and are between 18-80 years old. Currently, the study has 31 openings."
Answered by AI
Are elderly citizens being included in this clinical trial?
"Eligibility criteria for this clinical trial include being over 18 but under 80 years old."
Answered by AI
Pembrolizumab is usually given to patients with what type of cancer?
"Pembrolizumab is a medication that is most often used to stop the spread of cancer. In some cases, it can also be employed to treat malignant melanoma of skin, recurrent cervical cancer, and refractory, relapsed mediastinal large b-cell lymphoma."
Answered by AI
What are the medical researchers trying to achieve with this experiment?
"The goal of this medical trial is to assess the Pathological complete response (PathCR) rate over the course of 1 year. Additionally, researchers will also collect data on the secondary outcomes of Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate, Time to relapse (TTR), and Two-year relapse-free rate ."
Answered by AI
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