Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer.

February 20, 2026 updated by: Alshaimaa Eid, Assiut University

Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer: A Randomized Controlled Trial.

this is a randomized controlled trial aims to compare between patients with locally advanced pancreatic cancer treated with EUS-guided injection of gemcitabine in addition to systemic chemotherapy, versus those who treated with the standard systemic chemotherapy alone, regarding to(progression -free survival and response rate).

Researchers will compare Arm A: patients received EUS-FNI of gemcitabine plus standard systemic chemotherapy to Arm B : patients receiving the standard systemic chemotherapy alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pancreatic cancer (PC) is the seventh leading cause of global cancer deaths in the developed countries, and the third most common in the USA. Based on GLOBOCAN 2020 estimates, PC has ranked the 12th most common cancer in the world.

In Egypt, according to incidence rate; the PCs are the 11th most common malignancies and represent 2.2% of all cancers incidence. While according to mortality rate, PCs are the 8th of all deaths caused by cancer and represent 3.2%.

Pancreatic cancers are categorized into two main types based on the cell of origin: exocrine cancers, which are the most common (over 95% of cases) and begin in the cells lining the ducts, with adenocarcinoma being the most frequent type, and endocrine cancers (also called pancreatic neuroendocrine tumors) which are less common and start in hormone-producing endocrine cells.

according to National Comprehensive Cancer Network (NCCN 2025) resectability criteria: Locally advanced pancreatic cancer (stage 3) is defined as unresectable ( at the time of diagnosis) non-metastasized pancreatic cancer, but extend to the nearby blood vessels (solid tumor contact >180degree with the SMA or CA) .

Gemcitabine-based chemotherapy regimens have become the standard of care in LAPC. They have increased the chances of converting LAPC to resectable tumors . but chemoresistance to gemcitabine is increasing due insufficient drug delivery due to decreased microvascularity and stroma-induced chemoresistance (Desmoplastic Stroma).

EUS allows fine-needle injection (FNI) that may overcome problems associated with tumor-related desmoplasia. Increasing intratumoral chemo-therapy level.

We hypothesized that gemcitabine could be safely administered by EUS-FNI and potentially enhance the efficacy of conventional multimodality therapy for patients with PC.

This study aim to evaluate the rate of response and quality of life in patients with locally advanced pancreatic cancer treated with EUS-FNI of gemcitabine in addition to systemic chemotherapy.

Intervention:

Case group (EUS-FNI of gemcitabine):

Performed under general anesthesia. Linear array EUS scope used for tumor localization. Fine needle is advanced to the pancreatic mass. Gemcitabine dose 200mg/ml is used, we take 1ml of the vial and dilute it in 2 cm3 and dilute it in normal saline.

We inject 50% of the dose at perimeter of the lesion at the sites of local infiltration and 50% within the remainder of the tumor (7).

The procedure will be repeated every 4 weeks for up to 4 sessions, in addition to systemic chemotherapy.

So all patients of the case group will be treated for up to 4 cycles of both EUS-FNI of gemcitabine and systemic chemotherapy followed by either concurrent chemoradiotherapy or surgical removal.

Control group:

Will receive up to 4 cycles of the standard systemic chemotherapy followed by either concurrent chemoradiotherapy or surgical removal.

Follow up time:

Both groups of patients will be followed up for at least 12 months.

Follow up includes:

clinical assessment.. Imaging( MSCT abdomen, CT chest,and bone scan when needed). CA19.9

2.4.5 -Research outcome:

  1. Primary (main): . To compare between patients with locally advanced pancreatic cancer treated with EUS-guided injection of gemcitabine in addition to systemic chemotherapy, versus those who treated with the standard systemic chemotherapy alone, regarding to(progression -free survival and response rate).

  2. Secondary (subsidiary):

    1. Local tumor control (size reduction, necrosis on imaging).
    2. Safety and tolerability of the combined therapy.
    3. Quality of life in patients treated with combined therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 years old.
  • Patients recently diagnosed to have pancreatic adenocarcinoma based on histopathological examination.
  • Locally advanced potentially resectable pancreatic cancer . .Eastern Cooperative Oncology Group performance status of 0 to 1. .Signed informed consent.

Exclusion Criteria:

  • Age < 18 years old.
  • Metastatic pancreatic cancer.
  • prior pancreatic surgery or chemotherapy or radiotherapy. concurrent or prior malignancy. coexistent medical condition precluding protocol therapy.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
endoscopic ultrasound local chemotherapeutic drug injection in addition to systemic chemotherapy
Drug: endoscopic ultrasonograhy guided chemptherapy injection
endoscopic ultrasonograhy guided chemptherapy injection
No Intervention: B
patients who recieve chemotherapeutic drug only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
compare patients with locally advanced pancreatic cancer treated with EUS guided injection of gemcitabine plus systemic chemotherapy to those treated with the standard systemic chemotherapy alone, regarding to(progression -freesurvival and response rate)
Time Frame: every one month

The primary outcome of this study is to compare the progression-free survival between patients with locally advanced pancreatic cancer who receive EUS-guided injection of gemcitabine plus systemic chemotherapy (Arm A) and those who receive standard systemic chemotherapy alone (Arm B). Progression-free survival is defined as the time from randomization to the first documented progression of disease (as per RECIST criteria) or death, whichever occurs first.

The secondary outcome will be the comparison of the response rate between the two treatment arms. Objective response rate will be measured as the proportion of patients who achieve either complete response (CR) or partial response (PR) to treatment, according to RECIST criteria.

By evaluating both progression-free survival and response rate, the trial aims to determine whether the addition of EUS-guided gemcitabine injection enhances the effectiveness of systemic chemotherapy in treating locally advanced pancreatic cancer
every one month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: laila abd baqi tony, professor, Assiut University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04-2025-100437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data of the primary outcome

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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