Cetuximab - IRDye800 Intraoperative Fluorescence Imaging in Esophagectomy of Esophageal Cancer
Drug Safety ; Drug Specificity
About this trial
This is an interventional diagnostic trial for Drug Safety ; Drug Specificity focused on measuring Cetuximab-IRDye800, EGFR, esophageal squamous cell carcinoma, real-time imaging
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:
- Cetuximab drug allergy sufferers;
- Preoperative electrocardiogram indicates patients with prolonged QTc interval;
- People with mental or neurological diseases;
- Patients with cachexia and severe malnutrition;
- Patients with surgical contraindications such as coagulopathy, HIV antibody positive, and severely poorly controlled clinical infections;
- Patients with other combined diseases (such as abnormal liver and kidney function) or combined medications, which may be affected by the investigator.
- Patients who are simultaneously involved in another clinical study;
Sites / Locations
- The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Experimental
use of the cetuximab-IRDye800
four groups : control group, 1% dose group (1% of therapeutic dose; 2.5 Mg/m2) and 10% dose groups (10%of therapeutic dose ;25mg/m2) and 25% dose group (25%of therapeutic dose; 62.5mg/m2)