Cetuximab - IRDye800 Intraoperative Fluorescence Imaging in Esophagectomy of Esophageal Cancer

November 12, 2019 updated by: Fifth Affiliated Hospital, Sun Yat-Sen University

Cetuximab - IRDye800 Intraoperative Fluorescence Imaging in Esophagectomy of Esophageal Cancer:A Single Center Clinical Research

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Cetuximab-IRDye800
does of Cetuximab-IRDye800

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor to Background Ratio
Time Frame: intra-operative
Tumor to Background Ratio by mean fluorescence intensity in tumor tissue and lymph nodes
intra-operative
relative adverse drug reaction
Time Frame: 14 days after using cetuximab-IRDye800
relative adverse drug reaction after using cetuximab-IRDye800
14 days after using cetuximab-IRDye800

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIC-ESO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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