NCT03861702

Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

Completed Phase 2 Results posted Last updated 18 April 2025

What this trial tests

Phase 2 trial testing FOLFOX regimen in Locally Advanced Pancreatic Carcinoma(LAPC) in 28 participants. Completed in 27 September 2024.

Timeline

2 September 2020

Primary endpoint
16 August 2023

27 September 2024

Quick facts

Lead sponsor	Nelson Yee
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	2 September 2020
Primary completion	16 August 2023
Estimated completion	27 September 2024
Sites	4 locations across United States

Drugs / interventions tested

• FOLFOX regimen — full drug profile →
• Liposomal Irinotecan — full drug profile →

Conditions studied

• Locally Advanced Pancreatic Carcinoma(LAPC) — all drugs for Locally Advanced Pancreatic Carcinoma(LAPC) →

Sponsor

Nelson Yee

Who can join

18 and older, any sex, with Locally Advanced Pancreatic Carcinoma(LAPC). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Disease Control Rate (DCR) Primary · Up to 22 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Disease Control Rate (DCR) = CR +PR+SD

Group	Value	95% CI
FOLFOX + Irinotecan	73

Objective Response Rate (ORR) at 8 Weeks Secondary · 8 weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR.

Group	Value	95% CI
FOLFOX + Irinotecan	16

Objective Response Rate (ORR) at 16 Weeks Secondary · 16 weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR.

Group	Value	95% CI
FOLFOX + Irinotecan	21

Objective Response Rate (ORR) at 24 Weeks Secondary · 24 weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR.

Group	Value	95% CI
FOLFOX + Irinotecan	25

Stable Disease Rate (SDR) at 8 Weeks Secondary · 8 Weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) is determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 8 weeks following initiation

Group	Value	95% CI
FOLFOX + Irinotecan	84

Stable Disease Rate (SDR) at 16 Weeks Secondary · 16 Weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) as determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 16 weeks following initiatio

Group	Value	95% CI
FOLFOX + Irinotecan	89

Stable Disease Rate (SDR) at 24 Weeks Secondary · 24 Weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) as determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 24 weeks following initiatio

Group	Value	95% CI
FOLFOX + Irinotecan	80

Proportion of Subjects Able to Undergo Surgical Resection Secondary · 12 months

Rate of resectability as determined by the proportion of subjects who undergo surgical resection of tumors.

Group	Value	95% CI
FOLFOX + Irinotecan	0.095

Response of Serum CA19-9 Levels Secondary · Up to 7 months

A CA 19-9 test measures the amount of a protein called CA19-9 (cancer antigen 19-9) in a sample of blood. Healthy people can have small amounts of CA 19-9 in their blood. High levels of CA 19-9 are often a sign of pancreatic cancer. Increasing CA 19-9 levels mean the tumor is growing, whether decreasing CA 19-9 levels may mean the tumor is shrinking. The Mean of the percentage change from baseline in serum CA19-9 levels associated with best confirmed response (PR, SD, PD) per RECIST 1.1 are reported in the outcome measure data table.

Best response: PR

Group	Value	95% CI
FOLFOX + Irinotecan	-69	± 37.41

Best response: SD

Group	Value	95% CI
FOLFOX + Irinotecan	-41	± 40.87

Best response: PD

Group	Value	95% CI
FOLFOX + Irinotecan	31	± 8.04

Progression-Free Survival (PFS) Secondary · Up to 22 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Progression-free survival (PFS) as determined by the time interval from the date of first dose of study drug to first documented disease progression or death

Group	Value	95% CI
FOLFOX + Irinotecan	8.1	5.19 – 12.1

Overall Survival (OS) Secondary · Up to 31 months

Overall survival (OS) is defined as time from the first dose of study drug to date of death from any cause.

Group	Value	95% CI
FOLFOX + Irinotecan	18	11.3 – 22.5

Number of Participants With Adverse Events Secondary · Up to 7 months

Adverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Group	Value	95% CI
FOLFOX + Irinotecan	28

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to maximum 31 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FOLFOX + Irinotecan

Serious: 15/28 (54%)

Deaths: 13/28

Serious adverse events (21 terms)

Reaction	System	FOLFOX + Irinotecan
DIARRHEA	Gastrointestinal disorders	—
ACUTE KIDNEY INJURY	Renal and urinary disorders	—
ENTEROCOLITIS	Gastrointestinal disorders	—
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	—
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	Infections and infestations	—
ABDOMINAL PAIN	Gastrointestinal disorders	—
ALANINE AMINOTRANSFERASE INCREASED	Investigations	—
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	—
BILIARY TRACT INFECTION	Infections and infestations	—
CONSTIPATION	Gastrointestinal disorders	—
DEHYDRATION	Metabolism and nutrition disorders	—
ENTEROCOLITIS INFECTIOUS	Infections and infestations	—
GALLBLADDER INFECTION	Infections and infestations	—
GASTRITIS	Gastrointestinal disorders	—
HEPATOBILIARY DISORDERS - OTHER, SPECIFY	Hepatobiliary disorders	—
HYPOMAGNESEMIA	Metabolism and nutrition disorders	—
LUNG INFECTION	Infections and infestations	—
PANCREATITIS	Gastrointestinal disorders	—
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	—
URINARY TRACT INFECTION	Infections and infestations	—
VENTRICULAR TACHYCARDIA	Cardiac disorders	—

Other adverse events (144 terms — click to expand)

Reaction	System	FOLFOX + Irinotecan
DIARRHEA	Gastrointestinal disorders	—
FATIGUE	General disorders	—
ABDOMINAL PAIN	Gastrointestinal disorders	—
ANOREXIA	Metabolism and nutrition disorders	—
NAUSEA	Gastrointestinal disorders	—
CONSTIPATION	Gastrointestinal disorders	—
HYPERTENSION	Vascular disorders	—
GASTROESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	—
VOMITING	Gastrointestinal disorders	—
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	—
HYPOKALEMIA	Metabolism and nutrition disorders	—
PARESTHESIA	Nervous system disorders	—
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	Gastrointestinal disorders	—
INSOMNIA	Psychiatric disorders	—
WEIGHT LOSS	Investigations	—
ANEMIA	Blood and lymphatic system disorders	—
DIZZINESS	Nervous system disorders	—
NEUTROPHIL COUNT DECREASED	Investigations	—
ANXIETY	Psychiatric disorders	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—
DYSGEUSIA	Nervous system disorders	—
HYPERLIPIDEMIA	Metabolism and nutrition disorders	—
PLATELET COUNT DECREASED	Investigations	—
THROMBOEMBOLIC EVENT	Vascular disorders	—
ALOPECIA	Skin and subcutaneous tissue disorders	—
DYSPNEA	Respiratory, thoracic and mediastinal disorders	—
HEADACHE	Nervous system disorders	—
HICCUPS	Respiratory, thoracic and mediastinal disorders	—
HYPONATREMIA	Metabolism and nutrition disorders	—
MUCOSITIS ORAL	Gastrointestinal disorders	—
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	Musculoskeletal and connective tissue disorders	—
COUGH	Respiratory, thoracic and mediastinal disorders	—
DEHYDRATION	Metabolism and nutrition disorders	—
DRY MOUTH	Gastrointestinal disorders	—
EDEMA LIMBS	General disorders	—
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	—
FLATULENCE	Gastrointestinal disorders	—
HYPERGLYCEMIA	Metabolism and nutrition disorders	—
HYPOMAGNESEMIA	Metabolism and nutrition disorders	—
HYPOTENSION	Vascular disorders	—

Most-reported serious reactions: DIARRHEA, ACUTE KIDNEY INJURY, ENTEROCOLITIS, FEBRILE NEUTROPENIA, INFECTIONS AND INFESTATIONS - OTHER, SPECIFY, ABDOMINAL PAIN, ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED.

Data from ClinicalTrials.gov NCT03861702 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Progress of Nanocarrier-Based Therapy for Solid Malignancies.
   Wei QY, Xu YM, Lau ATY. · · 2020 · cited 60× · PMID 32998391 · DOI 10.3390/cancers12102783
2. Integration of liposomal irinotecan in the first-line treatment of metastatic pancreatic cancer: try to do not think about the white bear.
   Melisi D, Casalino S, Pietrobono S, Quinzii A, et al · · 2024 · cited 5× · PMID 38584763 · DOI 10.1177/17588359241234487