Fluorescent Navigation Technology in Radical Resection of Pancreatic Cancer (CISPD-6)

Exploratory Clinical Study of Fluorescent Navigation Technology Based on Anti-EGFR Antibody-IR800CW Novel Imaging Agent in Radical Resection of Pancreatic Cancer

This study intends to design the prospective, exploratory, single center clinical study, using targeted EGFR fluorescence imaging agent (anti-EGFR-IR800CW) and fluorescent navigation technology, in its lymph node tracing, intraoperative tumor localization, accurate determination of resection margin, and explore its clinical significance in radical surgical resection of pancreatic cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Pancreatic Adenocarcinoma
• Intervention / Treatment: Diagnostic test: Injection of fluorescent developer (anti-EGFR-IR800CW)

Detailed Description

The overall prognosis of pancreatic cancer is poor. For resectable patients, adjuvant chemotherapy is performed after surgery, which has become the standard and standard treatment recommended by various guidelines. Preoperative neoadjuvant therapy is proved to improve the R0 resection rate and reduce the lymph node metastasis rate, thus prolonging the postoperative recurrence-free survival time and increasing the survival benefit of patients. But despite adequate preoperative and postoperative treatment, the patient benefit remains limited. In pancreatic cancer surgery, improving the R0 resection rate, increasing the positive lymph node resection rate, and accurately identifying small metastases to accurately stage, can improve the prognosis of patients to a certain extent. Therefore, this study intends to design the prospective, exploratory, single center clinical study, using targeted EGFR fluorescence imaging agent (anti-EGFR-IR800CW) and fluorescent navigation technology, in its lymph node tracing, intraoperative tumor localization, accurate determination of resection margin, and explore its clinical significance in radical surgical resection of pancreatic cancer.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tingbo Liang, PhD; Phone Number: +86 19941463683; Email: liangtingbo@zju.edu.cn
• Study Contact Backup: Name: Yiwen Chen, MD; Phone Number: +86 15088682641; Email: cherry0705@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subjects voluntarily joined the study and signed the informed consent form; Age is greater than or equal to 18 years old (time for signing the informed consent form);
2. Minimally invasive radical surgical resection can be performed after discussion and evaluation of hepatobiliary and pancreatic surgery;
3. The patient and his family members volunteered to receive radical surgical resection of pancreatic cancer; Patients must have reliable contraception during the study and within 6 months after the study period;
4. negative serum pregnancy / urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects;
5. male subjects should agree to have contraception during the study and within 6 months after the end of the study period;

Exclusion Criteria:

1. Combined diseases and medical history:

1. Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
2. Within 5 years, the subject had previous or both other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); with other malignant tumors, but the following two conditions were enroll: other malignant tumors treated with single surgery with R0 resection and no recurrence for 5 years; cured cervical carcinoma in situ, skin basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];

2. There are surgical contraindications;

3. Study Treatment-Related to:

1. Previous history of severe allergy to macromolecular drugs, or allergy to known ingredients of EGFR injection;
2. Chronic treatment with systemic hormones or other immunosuppressive agents (dose> 10mg / day prednisone or other efficacy hormone) 28 days prior to the start of the study and continued hormone or immunosuppressive agents within 2 weeks after the first test administration, immunomodulators included: therapeutic vaccines, cytokine therapy, or subjects against CTLA 4,4-1BB, OX-40 (except for regular use, temporary);
3. Active autoimmune diseases requiring systemic treatment (e. g., corticosteroids or immunosuppressants) occurred within 2 years prior to the initiation of study treatment. Alternative therapies (e. g. thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered as systemic therapy;

4. According to the discretion of the investigator, subjects with serious hazards to subject safety or concomitant diseases completing the study, or no other reasons for the enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm A; The patient underwent Da Vinci robot or fluorescent laparoscopic-assisted radical resection of pancreatic cancer. The day before the operation, anti-EGFR antibody-IR800CW imaging agent was injected into the vein, and the fluorescence test was performed to evaluate the imaging of the primary lesions of the pancreas and the intra-abdominal lymph nodes. And to evaluate for the presence of imaging lesions in the liver, peritoneum, pelvic cavity, etc.

Diagnostic test: Injection of fluorescent developer (anti-EGFR-IR800CW); The patient underwent Da Vinci robot or fluorescent laparoscopy-assisted radical resection of pancreatic cancer, and anti-EGFR antibody-IR800CW imaging agent was injected in the day before surgery, and fluorescence detection was performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy and sensitivity of the imaging agent	Accuracy and sensitivity of anti-EGFR antibody-IR800CW imaging technology of primary pancreatic lesions and metastatic lymph nodes in radical resection of pancreatic cancer	1 month after enrolled

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: resectable pancreatic cancer; Fluorescence navigation technology
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CISPD-6

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