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

NCT ID: NCT04110769

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Genetic Change; Chemotherapy Effect; Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

next generation sequencing

Intervention Type: DIAGNOSTIC_TEST

the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.

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.

Group Type: ACTIVE_COMPARATOR

next generation sequencing

Intervention Type: DIAGNOSTIC_TEST

the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.

following next generation sequencing

Intervention Type: DIAGNOSTIC_TEST

The patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders.

Interventions

next generation sequencing

the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.

Intervention Type: DIAGNOSTIC_TEST

following next generation sequencing

The patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Song Cheol Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Song-Choel Kim, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Song-Choel Kim, MD.PhD

Role: CONTACT

drksc@amc.seoul.kr

82-2-3010-3933

Woohyung Lee, MD

Role: CONTACT

ywhnet@gmail.com

82-2-3010-3933

Facility Contacts

Woohyung Lee

Role: primary

ywhnet@gmail.com

230103933

Other Identifiers

NACTMarker-01

Identifier Type: -

Identifier Source: org_study_id