Locally Advanced Pancreatic Carcinoma(LAPC)Phase 2NCT03861702

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

A Phase 2 study testing FOLFOX regimen and Liposomal Irinotecan in people with Locally Advanced Pancreatic Carcinoma(LAPC), run by Nelson Yee at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Pancreatic Carcinoma(LAPC)
What is being tested?: FOLFOX regimen and Liposomal Irinotecan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 4 sitesUnited States
Study dates: 2 Sep 2020to 27 Sep 2024
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

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Histological or cytological confirmation of pancreatic carcinoma.
Measurable disease according to RECIST v1.1 within 28 days prior to registration.
Previously untreated pancreatic carcinoma considered as locally advanced unresectable according to NCCN guidelines.

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Demonstrate adequate organ function as defined in the table below; All screening labs to be obtained within 14 days prior to initiation of study treatment.
Hematological
Absolute Neutrophil Count (ANC): >/=1500/uL
Hemoglobin (Hgb): >/=8 g/dL with blood transfusion permitted
Platelet (Plt): >/=100,000/uL
Renal
Serum creatinine: </=1.5 x upper limit of normal (ULN) OR
Calculated creatinine clearance using the Cockcroft-Gualt formula: >/=50 mL/min for subjects with creatinine levels >1.5 ULN
Hepatic
Total bilirubin: </=1.5 x ULN (biliary drainage is allowed for biliary obstruction). Patients with Gilbert's syndrome with a total bilirubin </=3.0 x ULN and direct bilirubin within normal limits are permitted
Aspartate aminotransferase (AST): </=2.5 x ULN
Alanine aminotransferase (ALT): </=2.5 x ULN
Albumin: >/=3.0 g/dL
Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): </=1.5 x ULN unless subject is receiving anticoagulant therapy, as long as PT, INR or PTT is within therapeutic range of intended use of anticoagulants
Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days of study registration and within 72 hours of Cycle 1 Day 1. NOTE: Female subjects are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
Female subjects of childbearing potential and males must be willing to abstain from behaviors that could lead to pregnancy (heterosexual activity, sperm donation, in vitro fertilization, etc.) or to use 2 forms of effective methods of contraception from the time of informed consent until 9 months (females) or 6 months (males) after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study. The subject should be able to understand the purpose and risks of the study and provide a signed and dated informed consent form.

Who cannot join

Known hypersensitivity to irinotecan liposome, other liposomal products, oxaliplatin, 5-fluorouracil, leucovorin, or any ingredients in those preparations.
Pre-existing peripheral neuropathy (Grade 3 or 4) during screening.
Major surgery within 4 weeks of starting treatment.
Active uncontrolled cardiac arrhythmia or congestive heart failure (class 3 or 4 as defined by the New York Heart Association Functional Classification); or history of myocardial infarction, unstable angina; or acute coronary syndrome within 6 months prior to enrollment.
Known history of human immunodeficiency virus (HIV), or hepatic cirrhosis caused by active infection with hepatitis B virus (HBV, as defined by HBsAg positivity or positive DNA). Testing is not required for study entry if there is no clinical suspicion. Note: hepatic cirrhosis caused by other factors (ex. alcoholic cirrhosis) may be considered on a case-by-case basis if, in the opinion of the treating investigator, the disease is unlikely to compromise the subject's safety or put the study outcomes at unnecessary risk.
Any medical condition, life-threatening illness, or organ dysfunction, which in the investigator's opinion, can compromise the subject's safety or put the study outcomes at unnecessary risk.

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Uncontrolled active systemic infection.
Concomitant medications that are prohibited in this study and they cannot be switched to alternative medications.
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Known additional malignancy that is active and/or progressive requiring treatment within 2 years of screening for this study; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, low-grade prostate cancer, or other cancer for which the subject has been disease-free for at least five years. Additional exceptions could be considered if agreed by sponsor-investigator and site investigator assuming the disease is considered extremely unlikely to confound evaluation of disease status.
Treatment with any investigational drug within 30 days prior to registration, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing of this study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Rutgers Cancer Institute of new Jersey
New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: A Phase II Study to Evaluate the Efficacy of Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma: Big Ten Cancer Research Consortium BTCRC-GI15-067

Read the detailed 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). Each subject will be screened for eligibility by evaluation including medical history, physical examination, performance status, blood tests, computed tomographic (CT) scans, and electrocardiogram. Within 28 days of screening, the consented subjects will have a central venous access device placed and then start treatment.

For every 2-week cycle of FOLFOX-nal-IRI, each subject will receive nal-IRI (irinotecan free base 50 mg/m2 intravenously over 90 minutes), oxaliplatin (60 mg/m2 intravenously over 2 hours), leucovorin (400 mg/m2 intravenously over 2 hours), and 5-fluorouracil 2,400 mg/m2 intravenously over 46 hours).

Tumor response/surgical assessment will be evaluated after every 4 cycles of treatment with CT scans using RECIST 1.1 criteria. If the tumor becomes surgically resectable and the subject is a surgical candidate as determined by a multidisciplinary team, the subject will undergo surgery (at which point he/she would enter survival follow-up). If the tumor remains unresectable and there is no tumor progression, each subject will be treated up to a total of 12 cycles of FOLFOX-nal-IRI.

Following treatment with 12 cycles of FOLFOX-nal-IRI, if tumor remains unresectable, the subjects may receive further treatment (chemotherapy using the same regimen or of the treating physician's choice, or chemoradiation therapy) or observation as determined by the physician. During the course of treatment, if the subjects develop unacceptable toxicity and/or disease progression, the treatment will be discontinued, and the subjects will be further managed at the discretion of the treating oncologists.

Conditions: Locally Advanced Pancreatic Carcinoma(LAPC)
Being tested: FOLFOX regimen, Liposomal Irinotecan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOLFOX regimenDrug
FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil)
Liposomal IrinotecanDrug
Also called nal-Irinotecan
Liposomal Irinotecan

Study groups in NCT03861702
Study group	Role	What they receive
FOLFOX + Irinotecan	Experimental	Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. Receives: Drug: FOLFOX regimen; Drug: Liposomal Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease Control Rate (DCR)
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
Measured: Up to 22 months

Secondary outcomes (12)

Objective Response Rate (ORR) at 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.
Measured: 8 weeks
Objective Response Rate (ORR) at 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.
Measured: 16 weeks
Objective Response Rate (ORR) at 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.
Measured: 24 weeks
Stable Disease Rate (SDR) at 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 of FOLFOX-nal-IRI.
Measured: 8 Weeks
Stable Disease Rate (SDR) at 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 initiation of FOLFOX-nal-IRI.
Measured: 16 Weeks
Stable Disease Rate (SDR) at 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 initiation of FOLFOX-nal-IRI.
Measured: 24 Weeks
Proportion of Subjects Able to Undergo Surgical Resection
Rate of resectability as determined by the proportion of subjects who undergo surgical resection of tumors.
Measured: 12 months
Response of Serum CA19-9 Levels
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.
Measured: Up to 7 months
Progression-Free Survival (PFS)
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 from any cause, whichever occurs first.
Measured: Up to 22 months
Overall Survival (OS)
Overall survival (OS) is defined as time from the first dose of study drug to date of death from any cause.
Measured: Up to 31 months
Number of Participants With Adverse Events
Adverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Up to 7 months
Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30)
This secondary outcome measure evaluates overall quality of life using the Global Health Status scale from the EORTC QLQ-C30. Scores range from 0 to 100, with higher scores indicating better global health and quality of life. Mean (SD) scores are reported by assessment period, including only those participants who reached the defined time points (e.g., Cycle 9).
Measured: Treatment Cycle 1 (14 days), Treatment Cycle 5 (70 days), Treatment Cycle 9 (126 days), Follow-Up (7 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 202027 Sep 2024

First posted4 Mar 2019
Study start2 Sep 2020
Primary completion16 Aug 2023
Study completion27 Sep 2024

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 Locally Advanced Pancreatic Carcinoma(LAPC)Studies of the same condition, open and under way.
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
Model description: This is a phase II, single-arm, open-label, clinical study.
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03861702
Sponsor's protocol ID: BTCRC-GI15-067
Status last verified: Apr 2025
First submitted: 28 Feb 2019
Last updated: 18 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
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RecruitingPhase 1
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All Locally Advanced Pancreatic Carcinoma(LAPC) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study to Evaluate the Efficacy of Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma: Big Ten Cancer Research Consortium BTCRC-GI15-067
ClinicalTrials.gov ID: NCT03861702
Acronym / sponsor ID: BTCRC-GI15-067
Conditions: Locally Advanced Pancreatic Carcinoma(LAPC)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Nelson YeeUniversity, hospital or other
Collaborators: Ipsen
Study start: 2 Sep 2020 (actual)
Primary completion: 16 Aug 2023 (actual)
Study completion: 27 Sep 2024 (actual)
First posted: 4 Mar 2019 (actual)
Results: Posted 18 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a phase II, single-arm, open-label, clinical study.

Arm	Type	Receives
FOLFOX + Irinotecan	Experimental	Drug: FOLFOX regimen, Drug: Liposomal IrinotecanOxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Histological or cytological confirmation of pancreatic carcinoma.
Measurable disease according to RECIST v1.1 within 28 days prior to registration.

Key exclusion criteria (11 listed)

Known hypersensitivity to irinotecan liposome, other liposomal products, oxaliplatin, 5-fluorouracil, leucovorin, or any ingredients in those preparations.
Pre-existing peripheral neuropathy (Grade 3 or 4) during screening.
Major surgery within 4 weeks of starting treatment.
Active uncontrolled cardiac arrhythmia or congestive heart failure (class 3 or 4 as defined by the New York Heart Association Functional Classification); or history of myocardial infarction, unstable angina; or acute coronary syndrome within 6 months prior to enrollment.
Known history of human immunodeficiency virus (HIV), or hepatic cirrhosis caused by active infection with hepatitis B virus (HBV, as defined by HBsAg positivity or positive DNA). Testing is not required for study entry if there is no clinical suspicion. Note: hepatic cirrhosis caused by other factors (ex. alcoholic cirrhosis) may be considered on a case-by-case basis if, in the opinion of the treating investigator, the disease is unlikely to compromise the subject's safety or put the study outcomes at unnecessary risk.

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
FOLFOX regimenFOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil)	Drug	FOLFOX + Irinotecan
Liposomal IrinotecanAlso: nal-IrinotecanLiposomal Irinotecan	Drug	FOLFOX + Irinotecan

Primary outcome

Disease Control Rate (DCR)
Time frame: 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

12 secondary outcomes

Objective Response Rate (ORR) at 8 Weeks
Time frame: 8 weeks
Objective Response Rate (ORR) at 16 Weeks
Time frame: 16 weeks
Objective Response Rate (ORR) at 24 Weeks
Time frame: 24 weeks
Stable Disease Rate (SDR) at 8 Weeks
Time frame: 8 Weeks
Stable Disease Rate (SDR) at 16 Weeks
Time frame: 16 Weeks
Stable Disease Rate (SDR) at 24 Weeks
Time frame: 24 Weeks
Proportion of Subjects Able to Undergo Surgical Resection
Time frame: 12 months
Response of Serum CA19-9 Levels
Time frame: Up to 7 months
Progression-Free Survival (PFS)
Time frame: Up to 22 months
Overall Survival (OS)
Time frame: Up to 31 months
Number of Participants With Adverse Events
Time frame: Up to 7 months
Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30)
Time frame: Treatment Cycle 1 (14 days), Treatment Cycle 5 (70 days), Treatment Cycle 9 (126 days), Follow-Up (7 Months)

Results and safety

Results posted to the registry on 18 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FOLFOX + Irinotecan	28	28

Primary outcome: Disease Control Rate (DCR)

Time frame: Up to 22 months. Number. Unit: Percentage of participants

Measure	FOLFOX + Irinotecan n = 26
Value	73

Population analysed: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Disease Control Rate was defined as all participants who received at least one dose of trial drug and undergo at least one post-baseline disease assessment.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to maximum 31 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FOLFOX + Irinotecan	15 of 28 (53.6%)	28 of 28 (100%)	13 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Nelson Yee principal investigator

Penn State Cancer Institute

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 FOLFOX regimen and Liposomal Irinotecan in people with Locally Advanced Pancreatic Carcinoma(LAPC), run by Nelson Yee 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 23 inclusion and 11 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: finished, as of the sponsor's last update on 18 Apr 2025. 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 18 Apr 2025). 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?

Disease Control Rate (DCR) (time frame: Up to 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03861702.

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 18 Apr 2025.