Advanced Biliary Tract CancerPhase 2NCT04005339
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer
A Phase 2 study testing Nanoliposomal Irinotecan, Leucovorin and Fluorouracil in people with Advanced Biliary Tract Cancer, run by Georgetown University at 4 sites in United States.
Trial summary
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- Nanoliposomal Irinotecan, Leucovorin and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jul 2019to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic
- Disease progression on or intolerance of gemcitabine- and platinum-based chemotherapy
- No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count)
- Measurable disease by RECIST v1.1 criteria
- ECOG performance status of 0-1
- At least 18 years of age
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- HIV-positive patients are eligible provided: Stable HAART regimen, No concurrent prophylactic antibiotics or antifungals, and CD4 count above 250 and undetectable viral load
- Adequate bone marrow, hepatic, and renal function
- Consent to access archived tumor tissue if available (available tissue is not required for enrollment)
Who cannot join
- Ampullary adenocarcinoma
- Woman who are pregnant or breastfeeding
- Anti-cancer treatment within 3 weeks prior to enrollment
- Prior irinotecan or nanoliposomal irinotecan
- Central nervous system metastases unless stable for at least 4 weeks and at least 2 weeks off corticosteroids
- Exposure to a strong CYP3A4 inducer, strong CYP3A4 inhibitor, or strong UGT1A1 inhibitor within 2 weeks of study start
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- Known concurrent malignancy or other malignancy within 3 years except for non-melanomatous skin cancers, prostate or cervical cancers following curative therapy, or superficial bladder cancer
- Bowel obstruction
- Allergy or hypersensitivity to fluoropyrimidines, irinotecan, or nanoliposomal irinotecan
- Clinically significant liver disease: Patients with resolved hepatitis B infection are eligible if HBsAg testing is negative; Patients with resolved hepatitis C infection are eligible if viral RNA PCR is negative
- Severe infections within 4 weeks prior to enrollment
- Major surgery within 4 weeks prior to enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Icahn School of Medicine at Mount Sinai
New York, New York, 10128
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, 63110
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.
Read the detailed description
This is a single arm, open label, multicenter phase II study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy. Patients with advanced biliary tract cancers who have adequate performance status and adequate hepatic and renal function will be eligible. Patients may have received adjuvant chemotherapy and/or radiation therapy prior to enrolling in the trial, but a minimum of 6 months between adjuvant chemotherapy and this current therapy are required. Patients may continue on study as long as they are tolerating treatment and do not have progression of disease by RECIST v1.1 criteria. Response assessments will occur using imaging (CT or MRI) every 8 weeks.
- Conditions
- Advanced Biliary Tract Cancer
- Being tested
- Nanoliposomal Irinotecan, Leucovorin, Fluorouracil
- Keywords
- Advanced Biliary Tract Cancer, Biliary Tract Cancer, GI Cancer, Biliary Cancer, NAPOLI-2
- Medical subject headings
- Biliary Tract Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoliposomal IrinotecanDrug
Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days
LeucovorinDrug
Leucovorin 400 mg/ IV over 30 minutes, every 14 days.
FluorouracilDrug
Fluorouracil 2,400 mg/m IV over 46 hours.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days. Leucovorin 400 mg/ IV over 30 minutes, every 14 days. Fluorouracil 2,400 mg/m IV over 46 hours. Receives: Drug: Nanoliposomal Irinotecan; Drug: Leucovorin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Advanced Biliary Tract Cancers Following Progression on or Intolerance of Gemcitabine and Platinum Chemotherapy.
The number of participants with no evidence of disease progression (PD) at 4 months, as measured by RECIST v1.1 criteria.
Measured: 4 months
Secondary outcomes (7)
Overall Response Rate (ORR).
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy measured in terms of best overall response rate (ORR).
Measured: 6 months
Median Progression-free Survival (mPFS).
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy measured in terms of median progression-free survival (mPFS).
Measured: 6 months
Median Overall Survival (mOS).
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy measured in terms of median overall survival (mOS).
Measured: 6 months
Median Time to Disease Progression (mTTP).
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy measured in terms of median time to disease progression (mTTP).
Measured: 6 months
Disease Control Rate (DCR).
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy measured in terms of disease control rate (DCR).
Measured: 6 months
Median Duration of Disease Control (DDC).
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy measured in terms of median duration of disease control (DDC).
Measured: 6 months
Maximum Change in Tumor Marker, CA19-9.
The activity of fluorouracil, leucovorin, and nanoliposomal irinotecan in patients with advanced biliary tract cancers treated following progression on or intolerance of gemcitabine and platinum chemotherapy measured in terms of maximum change in tumor marker, CA19-9.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start29 Jul 2019
- Primary completion3 Sep 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Benjamin Weinberg, MD, Study chair, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005339
- Sponsor's protocol ID
- 2018-0877
- Status last verified
- Jan 2026
- First submitted
- 27 Jun 2019
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT04005339
- Acronym / sponsor ID
- 2018-0877
- Conditions
- Advanced Biliary Tract Cancer
- Keywords
- Advanced Biliary Tract Cancer, Biliary Tract Cancer, GI Cancer, Biliary Cancer, NAPOLI-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.
Detailed description
This is a single arm, open label, multicenter phase II study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy. Patients with advanced biliary tract cancers who have adequate performance status and adequate hepatic and renal function will be eligible. Patients may have received adjuvant chemotherapy and/or radiation therapy prior to enrolling in the trial, but a minimum of 6 months between adjuvant chemotherapy and this current therapy are required. Patients may continue on study as long as they are tolerating treatment and do not have progression of disease by RECIST v1.1 criteria. Response assessments will occur using imaging (CT or MRI) every 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Nanoliposomal Irinotecan, Drug: Leucovorin, Drug: FluorouracilNanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days. Leucovorin 400 mg/ IV over 30 minutes, every 14 days. Fluorouracil 2,400 mg/m IV over 46 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic
- Disease progression on or intolerance of gemcitabine- and platinum-based chemotherapy
- No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count)
- Measurable disease by RECIST v1.1 criteria
- ECOG performance status of 0-1
Key exclusion criteria (12 listed)
- Ampullary adenocarcinoma
- Woman who are pregnant or breastfeeding
- Anti-cancer treatment within 3 weeks prior to enrollment
- Prior irinotecan or nanoliposomal irinotecan
- Central nervous system metastases unless stable for at least 4 weeks and at least 2 weeks off corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanoliposomal IrinotecanNanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days | Drug | Single Arm |
| LeucovorinLeucovorin 400 mg/ IV over 30 minutes, every 14 days. | Drug | Single Arm |
| FluorouracilFluorouracil 2,400 mg/m IV over 46 hours. | Drug | Single Arm |
Primary outcome
The Efficacy of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Advanced Biliary Tract Cancers Following Progression on or Intolerance of Gemcitabine and Platinum Chemotherapy.
Time frame: 4 months
The number of participants with no evidence of disease progression (PD) at 4 months, as measured by RECIST v1.1 criteria.
7 secondary outcomes
Overall Response Rate (ORR).
Time frame: 6 months
Median Progression-free Survival (mPFS).
Time frame: 6 months
Median Overall Survival (mOS).
Time frame: 6 months
Median Time to Disease Progression (mTTP).
Time frame: 6 months
Disease Control Rate (DCR).
Time frame: 6 months
Median Duration of Disease Control (DDC).
Time frame: 6 months
Maximum Change in Tumor Marker, CA19-9.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Weinberg, MD study chair
Georgetown University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nanoliposomal Irinotecan, Leucovorin and Fluorouracil in people with Advanced Biliary Tract Cancer, run by Georgetown University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficacy of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Advanced Biliary Tract Cancers Following Progression on or Intolerance of Gemcitabine and Platinum Chemotherapy. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.