Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea

Pancreatic Neoplasms Clinical Trial

Official title:

Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587387
• Other study ID #: 4-2022-0776
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: October 2022
• Source: Yonsei University
• Contact: Seungmin Bang
• Phone: +82)10-6297-9209
• Email: bang7028[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreatic cancer is a very aggressive disease and its prognosis is poor. Large proportion of patients diagnosed with pancreatic cancer is already in metastatic or locally advanced phases. Although there have been huge improvements in survival for many other cancers over the last few decades, the same isn't true for pancreatic cancer. Median 5-year survival rate for pancreatic cancer is around 10% and there are limited number of treatments approved for pancreatic cancer.

There is no definite consensus on the best second-line chemotherapy for patients with metastatic pancreatic cancer who have progressed after first-line chemotherapy. The randomized phase III study, NAPOLI-1 trial has revealed that liposomal irinotecan (nal-IRI) plus fluorouracil/leucovorin (FL) regimen could be an acceptable treatment option in patients with metastatic pancreatic cancer who had been previously treated with gemcitabine-based chemotherapy.

In this study, The investigators will evaluate how the treatment landscape has been changed since the appearance of nal-IRI in Korea. By retrospectively comparing treatment efficacy and safety outcomes before (cohort 1; without nal-IRI/FL) and after the launch of nal-IRI (cohort 2; with nal-IRI/FL), investigators will identify the degree of improvement in treatment outcome brought about by nal-IRI and will confirm whether the nal-IRI could be applied as an effective treatment option in patients with metastatic pancreatic cancer who failed first-line chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients initially diagnosed as locally advanced pancreatic cancer or metastatic pancreatic cancer and received chemotherapy between 2012 and 2021

2. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas

3. Documented metastatic disease; disease status may be measurable or non-measurable as defined by RECIST v1.1 guidelines

4. Locally advanced pancreatic cancer; disease status was defined by NCCN guidelines.

5. Recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy

6. At least 18 years of age

Exclusion Criteria:

1. Other histology (ex. Neuroendocrine tumor, etc.)

2. Cohort 2 (other regimens); Patients who received nal-IRI at least once after diagnosis

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS1)	the duration from diagnosis of pancreatic cancer to death or last follow-up; - OS1 : the duration from diagnosis of pancreatic cancer to death or last follow-up	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks)
Primary	Overall survival (OS 2)	the duration from nal-IRI treatment initiation to death or last follow-up	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks)
Secondary	Progression free survival	the duration from treatment initiation to disease progression	The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse (Up to 100 weeks)
Secondary	Objective response rate	the ratio of complete remission and partial remission	The assessment of the tumor burden after a given treatment in patients with solid tumors and has a long history(Up to 100 weeks)
Secondary	Disease control rate	the ratio of complete remission, partial remission and stable disease	the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.(Up to 100 weeks)
Secondary	Adverse event	adverse event during the treatment	Any undesirable experience associated with the use of a medical product in a patient.(Up to 100 weeks)