Resectable Pancreatic AdenocarcinomaPhase 1/2CISPD-6NCT06168552
Fluorescent Navigation Technology in Radical Resection of Pancreatic Cancer
A Phase 1/2 study testing Injection of fluorescent developer (anti-EGFR-IR800CW) in people with Resectable Pancreatic Adenocarcinoma, run by Zhejiang University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Adenocarcinoma
- What is being tested?
- Injection of fluorescent developer (anti-EGFR-IR800CW)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 15 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- Minimally invasive radical surgical resection can be performed after discussion and evaluation of hepatobiliary and pancreatic surgery;
- 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;
- negative serum pregnancy / urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects;
- male subjects should agree to have contraception during the study and within 6 months after the end of the study period;
Who cannot join
- 1. Combined diseases and medical history:
- Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
- 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:
- Previous history of severe allergy to macromolecular drugs, or allergy to known ingredients of EGFR injection;
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- 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);
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Resectable Pancreatic Adenocarcinoma
- Being tested
- Injection of fluorescent developer (anti-EGFR-IR800CW)
- Keywords
- resectable pancreatic cancer, Fluorescence navigation technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of fluorescent developer (anti-EGFR-IR800CW)Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Diagnostic Test: Injection of fluorescent developer (anti-EGFR-IR800CW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168552
- Sponsor's protocol ID
- CISPD-6
- Acronym
- CISPD-6
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Fluorescent Navigation Technology Based on Anti-EGFR Antibody-IR800CW Novel Imaging Agent in Radical Resection of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06168552
- Acronym / sponsor ID
- CISPD-6 / CISPD-6
- Conditions
- Resectable Pancreatic Adenocarcinoma
- Keywords
- resectable pancreatic cancer, Fluorescence navigation technology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Diagnostic Test: Injection of fluorescent developer (anti-EGFR-IR800CW)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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);
- Minimally invasive radical surgical resection can be performed after discussion and evaluation of hepatobiliary and pancreatic surgery;
- 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;
- negative serum pregnancy / urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects;
- male subjects should agree to have contraception during the study and within 6 months after the end of the study period;
Key exclusion criteria (9 listed)
- Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
- 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;
- Previous history of severe allergy to macromolecular drugs, or allergy to known ingredients of EGFR injection;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Arm A |
Primary outcome
Accuracy and sensitivity of the imaging agent
Time frame: 1 month after enrolled
Accuracy and sensitivity of anti-EGFR antibody-IR800CW imaging technology of primary pancreatic lesions and metastatic lymph nodes in radical resection of pancreatic cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Injection of fluorescent developer (anti-EGFR-IR800CW) in people with Resectable Pancreatic Adenocarcinoma, run by Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingbo Liang, PhD (+86 19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and sensitivity of the imaging agent (time frame: 1 month after enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.