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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110769
• Other study ID #: NACTMarker-01
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Asan Medical Center
• Contact: Song-Choel Kim, MD.PhD
• Phone: 82-2-3010-3933
• Email: drksc[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Genetic Change
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• next generation sequencing
the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.
• following next generation sequencing
The patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders.

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of genetic mutation	Discovery of genetic mutation in response to neoadjuvant chemotherapy	before neoadjuvant chemotherapy
Secondary	oncologic outcome	overall survival and recurrence free survival	3 - 5 years after surgery