This is an open label, randomized phase 2 study of NaliCap (irinotecan liposome/Capecitabine) compared to NAPOLI (irinotecan liposome/5-FU/LV) in gemcitabine-pretreated advanced pancreatic cancer patients.
* At the time of initial diagnosis of pancreatic cancer, resectable pancreatic cancer is around 20%, locally-advanced pancreatic cancer is around 25-30%, and the remaining is metastatic pancreatic cancer. * In metastatic pancreatic cancer, Gemcitabine/Abraxane or FOLFIRINOX 5-fluorouracil/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) is most commonly used regimen as a palliative 1st-line chemotherapy. In gemcitabine-pretreated pancreatic cancer, irinotecan liposome(nal-IRI)/5-fluorouracil(5FU)/leucovorin(LV)(NAPOLI regimen) improved overall survival of patients compared to 5FU/LV. Now, NAPOLI is standard of care in gemcitabine-pretreated pancreatic cancer. * Oral 5-FU such as TS-1 is used in gemcitabine pretreated pancreatic cancer patients or 1st-line treatment in gemcitabine-intolerable patients. * Capecitabine is oral 5-FU, which is commonly used in GI cancers, usually replacing intravenous infusion of 5-FU. It improves patient's convenience not requiring vascular access or hospital admission. * In NAPOLI regimen, iv 5-FU/LV could be replaced with capecitabine. So far, nal-IRI/Capecitabine combination has not yet been tested. * Based on these rationale, we plan to conduct the open-label, randomized phase 2 study to assess the safety and efficacy of NaliCap (nal-IRI/Capecitabine) compared to NAPOLI (nal-IRI/5-FU/LV) in patients with gemcitabine-pretreated advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Seoul National University Bundang Hospital
Seongnam-si, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGProgression-free survival
Progression-free survival was defined as the duration between randomization and disease progression, any cause of death before disease progression, or the last follow-up.The event was defined as disease progression and any cause of death.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Objective response rate
Partial response and complete response
Time frame: through study completion, an average of 1 year
Overall survival
Overall survival was measured from the randomization to the last follow-up or any cause of death. The event was defined as any cause of death.
Time frame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 12 months
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE)\_ver 5.0 will be used.
Time frame: through study completion, an average of 1 year
QOL: eortc qlq-c30
eortc qlq-c30 will be used.
Time frame: through study completion, an average of 1 year
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NAPOLI