Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:
NCT03861702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-04-18
Summary
This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).
Conditions
- Locally Advanced Pancreatic Carcinoma(LAPC)
Interventions
- DRUG
-
FOLFOX regimen
FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil)
- DRUG
-
Liposomal Irinotecan
Liposomal Irinotecan
Sponsors & Collaborators
- collaborator INDUSTRY
-
Nelson Yee
lead OTHER
Principal Investigators
-
Nelson Yee · Penn State Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-02
- Primary Completion
- 2023-08-16
- Completion
- 2024-09-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Second-line Irinotecan Liposome Combination Regimen for Irinotecan-treated Pancreatic Cancer
NCT06700603 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
NCT02551991 ·Status: COMPLETED ·Phase: PHASE2
-
Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
NCT05074589 ·Status: COMPLETED ·Phase: PHASE3
-
Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV
NCT06782685 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer
NCT07238283 ·Status: RECRUITING ·Phase: PHASE3
-
Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab
NCT06172036 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer
NCT06387810 ·Status: RECRUITING ·Phase: PHASE2
-
Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
NCT07076212 ·Status: RECRUITING ·Phase: PHASE2
-
Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
NCT06571461 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
NCT01926197 ·Status: COMPLETED ·Phase: PHASE3
-
Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer
NCT06538623 ·Status: COMPLETED ·Phase: PHASE2
-
NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
NCT06941857 ·Status: RECRUITING ·Phase: PHASE2
-
Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer
NCT03703063 ·Status: UNKNOWN ·Phase: PHASE1
-
Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
NCT05047991 ·Status: UNKNOWN ·Phase: PHASE2
-
NALIRIFOX as Induction Therapy in LAPC
NCT06467565 ·Status: RECRUITING ·Phase: PHASE2
-
Second Line Treatment With Nal-IRI and S1 in Pancreatic Cancer
NCT03986294 ·Status: UNKNOWN ·Phase: PHASE2
-
Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas
NCT04617457 ·Status: RECRUITING ·Phase: PHASE2
-
Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan
NCT05095064 ·Status: UNKNOWN
-
A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
NCT07026123 ·Status: NOT_YET_RECRUITING
-
First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI
NCT03693677 ·Status: COMPLETED ·Phase: PHASE2
-
NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study
NCT06345300 ·Status: RECRUITING ·Phase: PHASE2
-
Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas
NCT06225999 ·Status: COMPLETED ·Phase: PHASE2
-
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
NCT06006728 ·Status: COMPLETED
-
OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] in Pancreatic Adenocarcinoma
NCT02368860 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
NCT03726021 ·Status: COMPLETED ·Phase: PHASE2