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

NCT07429643 | Not Yet Recruiting Phase 2

• 1 other identifier: 04-2025-100437
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Study Arms (2)

Arm A

EXPERIMENTAL

endoscopic ultrasound local chemotherapeutic drug injection in addition to systemic chemotherapy

Drug: endoscopic ultrasonograhy guided chemptherapy injection

B

NO INTERVENTION

patients who recieve chemotherapeutic drug only

Interventions

endoscopic ultrasonograhy guided chemptherapy injection DRUG

endoscopic ultrasonograhy guided chemptherapy injection

Arm A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• laila abd baqi tony, professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Al shaimaa Eid Abd El Tawab, Assisstant lecturer

CONTACT

201065803070; alshaimaaeid1995@yahoo.com

islam mohamed Abd El-Hameed, assisstant lecturer

CONTACT

201016329653; islammohamed846@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assiut city- assiut university street

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 24, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02