A Phase 1 interventional study of Cetuximab-IRDye800 in Drug Safety ; Drug Specificity, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Phase 1, Interventional, and Diagnostic
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. The molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors. The imaging probe possess high affinity to the tumor specific targets. Among the tumor related proteins, EGFR is located on the cell membrane and over expresses in more than 50% ESCC which has been used as an ideal target for molecular imaging.
Cetuximab is an EGFR targeting antibody for anti cancer therapy. When labeled with an commercial available fluorescence dye IRDye800, cetuximab has been used as molecular imaging probe in clinical trials for surgical navigation of cancers including head and neck squamous cell cancers and gliomas. Previous studies shown high safety when using this probe and excellence sensitivity for cancer detection, which bring great promise in translational medicine.
This is a single-center prospective sequential trial. It is the first attempt to apply cetuximab-IRDye800 probe in ESCC surgery. This probe will be produced under clinical Good Manufacturing Practice (cGMP) conditions. The ESCC patients will be recruited with strict criteria.Patients population is planned to be 40 cases between18 and 65 years old, without gender limit. The patients will be divided into four groups : control group without probe administration, 1% dose group (1% of therapeutic cetuximab dose; 2.5 Mg/m2) and 10% dose groups (10%of therapeutic cetuximab dose ;25mg/m2) and 25% dose group (25%of therapeutic cetuximab dose; 62.5mg/m2), 10 cases are sequential assigned to each group. After informed consent, patients will receive a systemic infusion of the study drug 2 days before surgery.
Primary (safety and efficiency) and secondary endpoints (tissue EGFR expression) will be recorded. Preoperative management and surgical procedures will been performed according to conventional protocols. Intra-operative imaging of the surgical field will be performed in real time at 2 time points: before and post tumor resection. The postoperative specimens will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice.
A protocol for managing any allergic reaction related to systemic infusion of cetuximab has been established. The patient's vital signs and ECG will be closely monitored post probe administration. The blood, liver and kidney, coagulation function and cardiotoxicity will be evaluated before and post surgery.
This clinical trial is anticipated to validate the concept that intra-operative fluorescent imaging of esophageal squamous cell carcinoma with cetuximab-IRDye800 can facilitate the demarcation of tumor boundary and identification of metastatic lymph nodes and testify its safety.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 40 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 57 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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)
Drug: Cetuximab-IRDye800
does of Cetuximab-IRDye800
Tumor to Background Ratio
Tumor to Background Ratio by mean fluorescence intensity in tumor tissue and lymph nodes
Time frame: intra-operative
relative adverse drug reaction
relative adverse drug reaction after using cetuximab-IRDye800
Time frame: 14 days after using cetuximab-IRDye800
Plan to share: No
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fifth Affiliated Hospital, Sun Yat-Sen University