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A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer

A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease

NCT02481635•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.

Detailed Description

Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Surgical:
•Medically fit for major pancreatic surgery
•No evidence of metastases
•No prior resection
•Arterial involvement limited to a single major vessel and is resectable
•Tumour-free margins could be achieved
•Acceptable length of vessel
•Mass considered otherwise resectable by current standards
•General:
•Less than 70 years old
+8 more criteria

Exclusion Criteria

•Surgical:
•Aortic involvement
•Involvement of 2 major arterial trunks
•SMV/portal venous occlusion, cannot be reconstructed
•Extensive venous involvement, no arterial involvement
•Disease progression on neo-adjuvant treatme
•General:
•Concurrent cancer diagnosis
•Other malignancies unless all therapy completed, no disease for \>=3 years
•Prior radiotherapy or chemo within 1 year, to pancreas
+14 more criteria

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

July 1, 2016

Primary Completion Date

December 10, 2024

Completion Date

January 1, 2026

Last Updated

December 8, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

Gemcitabine

DRUG

Nab-paclitaxel

DRUG

Radiation Therapy

RADIATION

Surgical Resection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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