NaliCap (Irinotecan Liposome (Nal-IRI)/Capecitabine) vs. NAPOLI (Nal-IRI/5-FU/LV) ) in Advanced Pancreatic Cancer (NaliCap)

April 17, 2024 updated by: Do-Youn Oh, Seoul National University Hospital

Randomized Phase II Study of NaliCap (Irinotecan Liposome/Capecitabine) Compared to NAPOLI (Irinotecan Liposome/5-fluorouracil/Leucovorin) in Gemcitabine-pretreated Advanced Pancreatic Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • 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

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seongnam-si, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Kim
        • Contact:
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent
  2. Age>20 years at time of study entry
  3. Histologically confirmed pancreatic ductal adenocarcinoma
  4. Advanced stage (unresectable, recurrent)
  5. Gemcitabine-pretreated for advanced pancreatic cancer
  6. Eastern Cooperative Oncology Group(ECOG) performance status 0, 1
  7. Adequate organ function
  8. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects.
  9. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  1. Participation in another clinical study with an investigational product (IP) during the last 3 weeks
  2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  3. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
  4. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  5. Known brain metastasis or spinal cord compression.
  6. History of allogenic organ transplantation
  7. Cardiac event during past 6 months
  8. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  9. Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive hepatitis B virus (HBV) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc (hepatitis B core antigen)] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  10. Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of IP.
  11. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  12. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NaliCap
nal-IRI/Capecitabine
Drug: Irinotecan Liposomal Injection [Onivyde]
both arm
Other Names:
  • nal-IRI
Drug: Capecitabine
NaliCap
Other Names:
  • xeloda
Active Comparator: NAPOLI
nal-IRI/5-FU/LV
Drug: Irinotecan Liposomal Injection [Onivyde]
both arm
Other Names:
  • nal-IRI
Drug: 5-fluorouracil
NAPOLI
Other Names:
  • 5FU
Drug: Leucovorin
NAPOLI
Other Names:
  • LV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
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
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: through study completion, an average of 1 year
Partial response and complete response
through study completion, an average of 1 year
Overall survival
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
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.
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
Time Frame: through study completion, an average of 1 year
Common Terminology Criteria for Adverse Events (CTCAE)_ver 5.0 will be used.
through study completion, an average of 1 year
QOL: eortc qlq-c30
Time Frame: through study completion, an average of 1 year
eortc qlq-c30 will be used.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Do-Youn Oh, M.D., PhD., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1912-090-1089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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