Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04161560
Eligibility Criteria:
Inclusion Criteria:
1.18 years old ≤ age ≤ 65 years old, gender is not limited; 2. Esophageal squamous cell carcinoma confirmed by cytology or histology and requiring surgical treatment; 3. Preoperative high-grade gastroscopy confirmed that the tumor staging was T1-3N0-1M0 patients feasible for surgical resection; 4. The main organ function is basically normal: Karnofsky score \>70%; 5. Laboratory blood tests meet surgical safety standards; 6. Informed consent form is signed before the study, the patient and / or their legal representative have the ability to fully understand the content of the trial, the process and possible adverse reactions, and the patients are able to comply for regular visit; 7. Women of reproductive age must have a negative pregnancy test and are not breastfeeding, both men and women need to receive contraceptive methods approved by the investigator and agree to maintain this contraceptive from the date of signing the informed consent to the end of the study.
Exclusion Criteria:
1. Cetuximab drug allergy sufferers;
2. Preoperative electrocardiogram indicates patients with prolonged QTc interval;
3. People with mental or neurological diseases;
4. Patients with cachexia and severe malnutrition;
5. Patients with surgical contraindications such as coagulopathy, HIV antibody positive, and severely poorly controlled clinical infections;
6. Patients with other combined diseases (such as abnormal liver and kidney function) or combined medications, which may be affected by the investigator.
7. Patients who are simultaneously involved in another clinical study;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04161560
Study Brief:
Protocol Section:
NCT04161560