Development of Biomarker for the Evaluation of Response After Neoadjuvant Therapy in Patients With Pancreatic Cancer

The purpose of this study is to identify and apply biomarkers that can provide better information than previous imaging and blood tests when evaluating the response after neoadjuvant chemotherapy in pancreatic cancer patients who require neoadjuvant therapy before surgery.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Chemotherapy Effect; Genetic Change
• Intervention / Treatment: Diagnostic test: next generation sequencing; Diagnostic test: following next generation sequencing

Detailed Description

BACKGROUND

• Pancreatic cancer is a rare cancer of the digestive system, but it is known to have a poor prognosis with a very poor survival rate. Five-year survival rate of all patients with pancreatic cancer is less than 6%, and only 10-20% of patients are eligible for surgery at the time of diagnosis.
• Postoperative complications of pancreatic cancer are reported in 30-50% of cases, and only 50% of patients undergoing postoperative chemotherapy at the appropriate time after surgery are reported. As a result of these concerns, the study of neoadjuvant chemotherapy (NACT) was begun. Recently, several clinical studies of chemotherapy have been performed. Cancer (BRPC), locally advanced pancreatic cancer (LAPC) patients who have had difficult surgical resection, are turning to treatment by combining surgical treatment after NACT.
• Although standard treatments for advanced chemotherapy have yet to be established through many clinical studies, the most commonly used regimens are FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), gemcitabine and nab-paclitaxel. The response rate after prior chemotherapy is known as 30-50%, and the response of patients undergoing surgery after prior chemotherapy was compared with the serum markers before and after chemotherapy through CA19-9, PET-CT, and CT. The response could be estimated by the reduction, the size change in the imaging test, or the decrease in SUVmax. However, there are only a few studies on genetic and molecular studies of which patients will respond. Under these circumstances, this study on the discovery of biomarkers for the response of advanced chemotherapy in patients with pancreatic cancer may provide guidelines for the application of advanced chemotherapy and the selection of appropriate drugs, as well as clues for future research.

Primary endpoint:

-Discovery of genetic mutation in response to NACT

METHODOLOGY Recruitment and sample collection of patients undergoing NACT Identifying pancreatic cancer specific candidate genes in response to NACT

EXPECTED RESEARCH RESULTS

• Predictable genes and biomarkers of responsiveness for NACT can be identified.
• It is possible to understand the progress of pancreatic cancer widely
• The development of biomarkers that can predict the response of NACT
• In patients with BRPC or LAPC who need NACT, appropriate screening will be possible.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Song-Choel Kim, MD.PhD; Phone Number: 82-2-3010-3933; Email: drksc@amc.seoul.kr
• Study Contact Backup: Name: Woohyung Lee, MD; Phone Number: 82-2-3010-3933; Email: ywhnet@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
    • Contact: Woohyung Lee; Phone Number: 230103933; Email: ywhnet@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients who are going to administer neoadjuvant chemotherapy for borderline resectable or locally advanced pancreatic cancer
• Performance: 0-2
• No distant metastasis
• Patients who consented to and signed the consent

Exclusion Criteria:

• Distant metastasis
• Patients included in other clinical studies that may affect this study
• Patients who cannot follow the directions of the researcher
• Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
• Pelvic tumor, benign tumor, malignant tumor in other organs
• Patients who received prior chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Responders; The investigator will administer neoadjuvant chemotherapy After neoadjuvant chemotherapy, multidisciplinary team will decide to surgery or continuing chemotherapy based on following imaging studies and tumor markers. The patients who undergo surgery after neoadjuvant chemotherapy will be included responders.	Diagnostic test: next generation sequencing; the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.
ACTIVE_COMPARATOR: Non-responders; The patients who show cancer progression even after neoadjuvant chemotherapy will be classify with non-responder. And the investigator will change palliative chemotherapy.	Diagnostic test: next generation sequencing; the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.; Diagnostic test: following next generation sequencing; The patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of genetic mutation	Discovery of genetic mutation in response to neoadjuvant chemotherapy	before neoadjuvant chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oncologic outcome	overall survival and recurrence free survival	3 - 5 years after surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Song-Choel Kim, MD.PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2019
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: September 28, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: NACTMarker-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No