AzTrials
AzTrials

Pancreatic Ductal AdenocarcinomaPhase 2NCT06467565

NALIRIFOX as Induction Therapy in LAPC

A Phase 2 study testing Liposomal irinotecan in people with Pancreatic Ductal Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Liposomal irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
25 Dec 2023to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old, ≤ 70 years old, male or female;
  • Understand the objectives and benefits and risks of the clinical trial, voluntarily participate in and sign the informed consent form;
  • ECOG score 0-1;
  • The subject had histopathologically or cytologically confirmed type of pancreatic ductal adenocarcinoma
  • Local progression according to the 2022 CSCO guidelines;
  • Initial subjects with locally advanced pancreatic cancer who have not undergone resection of pancreatic tumor (except open exploration or internal drainage surgery), chemotherapy, targeted, or immunotherapy.
Show all 22Show fewer
  • At least one measurable pancreatic lesion per RECIST 1.1 criteria;
  • Expected survival time ≥ 3 months.
  • Heart, lung, liver, kidney and other major organ functions are basically normal.
  • Hematology tests should meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to hematology):
  • White blood cell count ≥ 3.0 × 109/L and neutrophil count ≥ 1.5 × 109/L.
  • Platelet count ≥ 100 × 109/L.
  • Hemoglobin ≥ 90 g/L.
  • If component blood transfusions (red blood cells, platelets, etc.) are received at screening, reexamination of hematology must be performed at 1-week intervals before further screening can be considered.
  • Blood chemistry tests should meet the following criteria:
  • Plasma total bilirubin ≤ 1.5 × upper limit of normal.
  • ALT, AST, or ALP ≤ 2.5 × upper limit of normal;
  • Creatinine clearance ≥30 mL/min calculated by the Cockcroft-Gault formula (Cockcroft-Gault formula: male Ccr = [(140-age) × body weight (kg)]/[0.818 × Scr (μmol/L)] or Ccr = (140-age) × body weight (kg)/72 × Scr (mg/dl), and female Ccr calculated as male × 0.85);
  • The subject had no symptoms of cardiac insufficiency (NYHA functional class ≤ II) at baseline and had no obvious abnormalities or abnormalities in electrocardiograms that were not clinically significant.
  • Good compliance, voluntary compliance with this clinical trial protocol and follow-up by the investigator during the study.
  • Subjects of childbearing potential voluntarily take highly effective contraceptive measures in the trial.
  • Females must be non-lactating.

Who cannot join

  • Known allergy or intolerance to the ingredients or excipients of this investigational product.
  • Any metastatic lesions.
  • Patients with unresolved acute or chronic infection
  • Other malignancies within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Active hepatitis.
  • Patients with portal hypertension or cavernous transformation of the portal vein; patients with gastrointestinal bleeding caused by tumor involving the digestive tract; patients with intra-abdominal fistula or abscess due to tumor involvement of digestive tract; the tumor encircles the celiac trunk or SMA and causes significant vascular wall involvement (worm-like changes);
Show all 22Show fewer
  • Presence of third space effusion that cannot be controlled by drainage or other means (e.g., moderate-large pleural effusion, moderate-large pericardial effusion, ascites); a small amount of pleural effusion or ascites that is not clinically symptomatic and does not require clinical intervention should be strictly controlled before enrollment.
  • Mental illness or mental disorder, poor compliance, unable to cooperate with treatment
  • Patients with severe organic diseases or major organ failure, such as decompensated heart and lung failure, which lead to intolerance to chemotherapy.
  • Abnormal coagulation (INR > 1.5, APTT > 1.5 ULN), bleeding tendency (e.g., active ulcer lesions in the stomach, occult blood in stool (+ +), melena and/or hematemesis within 3 months, hemoptysis) or near the location of the lesion to major vessels.
  • Patients with Grade I or higher coronary heart disease, arrhythmia (including QTc prolongation > 450 ms in males and > 470 ms in females), taking arrhythmic drugs, or associated underlying heart disease and cardiac insufficiency.
  • Patients with renal insufficiency, previous renal disease, and positive urine protein (urine protein test 2 + or more, or 24-hour urineprotein quantitation > 1.0 g).
  • Organ transplant recipients.
  • There are drug addicts and other adverse drug addicts, long-term alcoholics and AIDS and other infectious diseases.
  • Long-term use of corticosteroids or immunosuppressants.
  • Those who have received vaccines (including live and live attenuated vaccines) within 4 weeks prior to enrollment, such as measles, mumps, rubella, varicella, yellow fever, rabies, BCG, and typhoid (oral) vaccines, etc., or who plan to be vaccinated during study dosing; Allowing all types of COVID-19 vaccines.
  • Subjects with active hepatitis B or hepatitis C (HBV DNA ≥ 1 × 104 copies or ≥ 2000 IU/mL regardless of drug control; hepatitis C infection, HCV RNA ≥ 15 IU/mL); or HIV antibody positive (testing is not required if there is no clinical evidence of possible HIV infection); or syphilis antibody (TPPA) positive.
  • Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 6 months following the last dose of nal-IRI. Females of Childbearing Potential must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index < 1) or agree to use effective contraception during treatment and for at least 7 months after last application of program treatment. Males with female partners of reproductive potential should use condoms during treatment and for 4 months after the last dose. A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile. Males must agree not to father a child (including not donating sperm) during the course of the trial and for at least 6 months after last administration of study drugs.
  • In the opinion of the investigator, the subject is unable to complete the entire trial process or other circumstances that are not suitable for participation in this trial.
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. Subjects are ineligible if:
  • they are unable to discontinue the use of strong inhibitors of CYP3A, CYP2C8 and UGT1A1 at least 1 week prior to first dosing
  • they are unable to discontinue the use of strong CYP3A and CYP2C8 inducers at least 2 weeks prior to first dosing.

Trial locations and contacts

1 site in 1 country.

Rong K Jiang, MD contact

+8615312995688

jiangkuirong@njmu.edu.cn

Min Tu, MD contact

China1 site, 1 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 025

    KuiRong Jiang, archiater, 15312995688, Jiangkuirong@163.com

    Min Tu, associate doctor

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study of Liposomal Irinotecan (Nal-IRI) With 5 Fluorouracil, Leucovorin, and Oxaliplatin (NALIRIFOX) in Patients With Locally Advanced Pancreatic Cancer

This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.

Read the detailed description

Subjects will be treated with the NALIRIFOX regimen every 2 weeks in 4-weeks cycles Imaging of tumor lesions will be performed after the subject has completed the first 2 cycles of treatment, and if the subject has not progressed, the subject will continue treatment until surgical resection, disease progression (RECIST 1.1) or intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up. All treated subjects will be evaluated for response while on this treatment every 8 weeks (±7) days after until surgical resection, disease progression (RECIST 1.1), intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up.. After 24 weeks of treatment, capecitabine or S-1 is the maintenance regimen. Radiographic response will be evaluated every 12 weeks (± 7 days) during the maintenance phase.

Being tested
Liposomal irinotecan

What participants receive

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

  • Liposomal irinotecanDrug

    NALIRIFOX（Oxaliplatin 60 mg/m2 IV over 2 hours ; Liposomal Irinotecan 50 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion） on days 1 of a 14-day cycle.

Study groups in NCT06467565
Study groupRoleWhat they receive
NALIRIFOXExperimentalNALIRIFOX（Oxaliplatin 60 mg/m2 IV over 2 hours ; Liposomal Irinotecan 50 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion） on days 1 of a 14-day cycle.
Receives: Drug: Liposomal irinotecan

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.

    Measured: Up to 1 year

Secondary outcomes (3)

  1. Progression free survival (PFS)

    PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.

    Measured: Up to two years

  2. Overall survival (OS)

    The duration from the date of recruitment to the date of death from any cause.

    Measured: Up to two years

  3. Adverse events (safety)

    Adverse events (safety ) will be evaluated according to the NCI CTCAE Version 5.0.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.

    Measured: Up to two years

Timeline

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

  1. First posted21 Jun 2024
  2. Study start25 Dec 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06467565
Sponsor's protocol ID
2023-SR-254
Status last verified
Jun 2024
First submitted
15 Jun 2024
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liposomal irinotecan in people with Pancreatic Ductal Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

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 22 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rong K Jiang, MD (+8615312995688, jiangkuirong@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 1 year). 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 NCT06467565.

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 21 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in