Clinical trial · Observational
Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Without Nal-IRI/FL; From Jan. 2012 to Jan. 2018 (Before launch of nal-IRI)
- label
- Cohort 2
- description
- With Nal-IRI/FL; From Jan. 2018 to Dec. 2021 (After launch of nal-IRI)
Primary outcomes (2)
- measure
- Overall survival (OS1)
- timeFrame
- 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)
- description
- 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
- measure
- Overall survival (OS 2)
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available