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Immunotherapy + Chemoradiotherapy for Gastroesophageal Cancer
Study Summary
This trial tests immunotherapy with chemo/radiotherapy to treat unresectable gastroesophageal cancer.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have an autoimmune disease treated with medication in the last 2 years.I have been treated with specific immune therapy drugs before.I am on replacement therapy like thyroxine or insulin, not systemic treatment.My brain cancer has not worsened recently.I have not had serious heart problems in the last 6 months.My cancer in the stomach or esophagus cannot be removed by surgery.I have fluid buildup in my abdomen or chest but am stable after treatment.I have mild to severe nerve damage in my hands or feet.I am highly allergic to pembrolizumab or its ingredients.My blood clotting tests are normal or within the treatment range if I'm on blood thinners.I have not received any colony-stimulating factors in the last 2 weeks.I have recovered from any major surgery before starting the study.My kidney function tests are within the required range.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.My cancer is advanced and cannot be removed by surgery, or I chose not to have surgery.My brain metastases are stable, and I haven't needed steroids for 14 days.I have had pneumonitis treated with steroids or have it now.I have had treatment for cancer that includes trial medicines.I am currently being treated for an infection.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant, not breastfeeding, and meet one of the specified conditions.I may need a blood transfusion due to my tumor causing blood loss.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a history of hepatitis B or active hepatitis C.I have had radiation therapy for my current illness.I have not received a live vaccine in the last 30 days.My cancer is only in my stomach and not near the area where my stomach meets my esophagus.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have cancer that has spread to my brain or spinal cord.I have received an organ or tissue transplant from another person.I have another cancer that is getting worse or was treated in the last 2 years.I can undergo endoscopic biopsies and give blood for research.I had skin or early cervical cancer but was treated with the intent to cure.
- Group 1: Treatment (pembrolizumab, chemoradiotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 medical conditions has Pembrolizumab been approved to treat?
"Pembrolizumab has been found to be effective in treating malignant neoplasms and other health issues such as unresectable melanoma, rectal carcinoma, and microsatellite instability high."
Has the FDA granted its official authorization for Pembrolizumab?
"Limited data on pembrolizumab's safety and efficacy has caused our team to assign it a rating of 1."
What is the total sample size of this research experiment?
"Affirmative. Clinicaltrials.gov indicates that the trial, which was first published on September 16th 2020, is currently seeking participants. 15 individuals must be recruited from a single clinical site."
Are there any vacancies in this trial for participants?
"Via clinicaltrials.gov, we know that this medical study is actively seeking participants. The trial was originally published on September 16th 2020 and recently edited as of October 10th 2022."
Are there any existing reports of Pembrolizumab being tested in other research projects?
"As of the present day, 1653 separate experiments are exploring Pembrolizumab's capabilities with 375 trials within Phase 3. Guangzhou, Guangdong is a particularly active location in regard to these studies; however, there exists 71618 other sites engaging in research involving Pembrolizumab."
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