EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01834170

Enrollment

Registered

2013-04-17

Start date

2013-04-30

Completion date

2014-12-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic cancer, Pancreatic adenocarcinoma, Endoscopic ultrasound

Brief summary

Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%. About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels. The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description

In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Interventions

DRUGGemcitabine

Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3. The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor

Exclusion criteria

* Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging * Pancreatic cancer with distant metastasis * Unwilling to sign informed consent

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events as a measure of safety and tolerability	6 months

Secondary

Measure	Time frame
Proportion of participants who remain alive one year after enrollment compared to the historical matched control group	1 year

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026