Clinical trial: NCT03792347
Section: Confidentiality
Subsections: Is My Information Confidential?

All information about you is kept strictly confidential during the research process. Only relevant personnel can view your medical records so that they can check the accuracy of the information collected and ensure that the research is conducted normally. Any information transmitted electronically will be renamed to ensure the confidentiality of the information. The information on all computers will be protected with a password. The results of the study may be reported at medical conferences and published in scientific journals. However, any information that identifies you personally will not be used.
Clinical trial: NCT03792347
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Is This Research Risky?

If you agree to participate in the study, we need to collect your tumor tissue and blood specimen. Blood specimen will be drawn during each routine blood test, and tumor 2 tissue will be obtained during surgery. These procedures will not make extra harm to your body. Chemoradiotherapy and surgery are routine treatment care, which has its potential risk and adverse events. Pembrolizumab may potentially cause several side effects including: 1. Immune-mediated pneumonitis; 2. Immune-mediated colitis; 3. Immune-mediated hepatitis; 4. Immune-mediated endocrinopathies; 5. Immune-mediated nephritis and renal dysfunction; 6. Immune-mediated skin adverse reactions; 7. Immune-mediated encephalitis; 8. Embryo-fetal toxicity.
Clinical trial: NCT03792347
Section: Purpose of Research
Subsections: What Is The Purpose Of The Research?

Chemoradiotherapy followed by surgery is the recommended treatment for locally advanced esophageal squamous cell carcinoma (ESCC). Pembrolizumab is an immune checkpoint inhibitor, which has been considered to be safe and effective for patients with advanced esophageal cancer. However, the effectiveness and safety of pembrolizumab in patients with locally advanced ESCC hasn't been verified. This study was designed to investigate the safety and feasibility of preoperative pembrolizumab combined with chemoradiotherapy for patients with locally advanced ESCC.
Clinical trial: NCT03792347
Section: Voluntary Participation
Subsections: Do I Have To Participate?

Participation in the study is entirely voluntary, not forced to participate. If you are participating in a study, you can opt out at any time without any reason. No matter what your decision is, it will not affect your normal treatment or your relationship with your healthcare provider. If you decide to participate, we will ask you to sign an informed consent form. You will keep a copy of this consent form.