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Pancreatic CancerPhase 1/2NCT06259058

Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer

A Phase 1/2 study testing Irinotecan liposome injection, Oxaliplatin and 5-Fluorouracil in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Irinotecan liposome injection, Oxaliplatin and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 1 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥18 years old.
  • Histologically or cytologically proven pancreatic ductal adenocarcinoma.
  • Multidisciplinary assessment as borderline resectable disease.
  • At least one measurable lesion (according to RECIST v1.1).
  • No prior antitumor therapy for pancreatic cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1.
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  • The expected survival time ≥3 months.
  • Adequate bone marrow function as evidenced by: 1) Absolute neutrophil count (ANC) ≥1.5×10^9/L, 2) Platelet count ≥100×10^9/L, 3) Hemoglobin (Hb) ≥90 g/L, 4) White blood cell (WBC) ≥3.0×10^9/L.
  • Adequate hepatic function as evidenced by: 1) Serum total bilirubin ≤1.5 × upper limit of normal (ULN), 2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
  • Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.
  • Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.

Who cannot join

  • Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
  • Patients with distant metastases and/or cannot complete resection.
  • Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
  • Active HIV, HBV, HCV infection.
  • Combined with uncontrollable systemic diseases.
  • Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction [CTCAE v5.0], or > grade 1 diarrhea [CTCAE v5.0]).
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  • History of allergy or hypersensitivity to drug or any of their excipients.
  • Patients who have chemotherapy and surgery contraindications.
  • Documented serum albumin ≤3 g/dL
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration.
  • Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
  • Participated in other trial within 30 days before the first administration.
  • Patients who are not suitable to participate in this trial for any reason judged by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chuntao Gao, Professor contact

022-2340123 ext. 3077

gaochuntao@tjmuch.com

About this study

Official title: Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer: a Phase Ib/II, Multicenter, Open-label Trial

This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).

Read the detailed description

Neoadjuvant chemotherapy or chemoradiotherapy can increase the R0 resection rate and improve survival in BRPC. However, there is no standard treatment regimen. The National Comprehensive Cancer Network (NCCN) guidelines recommend FOLFIRINOX (irinotecan + oxaliplatin +5-FU/LV) and FOLFIRINOX+ chemoradiotherapy for PDAC neoadjuvant treatment.

Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose,improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of NALIRIFOX + surgery + NALIRIFOX or surgery + NALIRIFOX in high-risk patients with resectable pancreatic cancer.

Being tested
Irinotecan liposome injection, Oxaliplatin, 5-Fluorouracil, Leucovorin, SBRT
Keywords
borderline resectable, NALIRIFOX, stereotactic body radiation therapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Irinotecan liposome injectionDrug

    Also called Nal-IRI

    50 mg/m² on Day 1 of a 14-day cycle

  • OxaliplatinDrug

    Also called Eloxatin

    60 mg/m² on Day 1 of a 14-day cycle

  • 5-FluorouracilDrug

    Also called 5-FU, flurouracil, Adrucil

    2400 mg/m² continuous IV infusion in 46 h

  • LeucovorinDrug

    Also called Folinic Acid

    400 mg/m² on Day 1 of a 14-day cycle

  • SBRTRadiation

    30Gy/5Fx

Study groups in NCT06259058
Study groupRoleWhat they receive
NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOXExperimentalPatients receive 3 cycles of NALIRIFOX followed by SBRT (30Gy/5Fx). Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
Receives: Drug: Irinotecan liposome injection; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Leucovorin; Radiation: SBRT
NALIRIFOX + Surgery + NALIRIFOXActive comparatorPatients receive 6 cycles of NALIRIFOX. Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
Receives: Drug: Irinotecan liposome injection; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Leucovorin

What is being measured

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

  1. R0 resection rate

    Defined as the proportion of patients who have achieved R0 resection.

    Measured: 4 months

Secondary outcomes (6)

  1. Objective Response Rate

    Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1

    Measured: 3 months

  2. Surgical Conversion Rate (R0 / R1 resection)

    Defined as the percentage of patients that underwent a R0/R1 resection.

    Measured: 4 months

  3. Tumor regression grade

    The classification is mainly based on the proportion of residual tumors and fibrosis in the primary tumor, used to evaluate the patient's response to neoadjuvant therapy and predict prognosis.

    Measured: 4 months

  4. Event-free Survival

    Defined as the time between signing the informed consent form to the first documentation of 1) disease progression (local recurrence, new lesions or distant metastasis), 2) a second malignant tumor occurs, or 3) death due to any cause.

    Measured: 1 year

  5. Overall survival

    Defined as the time between signing the informed consent form and death due to various causes.

    Measured: 2 years

  6. Incidence of adverse events

    Use NCI-CTCAE version 5.0 for classification and grading.

    Measured: 7 months

Timeline

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

  1. First posted14 Feb 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Dec 2027 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06259058
Sponsor's protocol ID
CSPC-DEY-PC-K04
Status last verified
Feb 2024
First submitted
6 Feb 2024
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Irinotecan liposome injection, Oxaliplatin and 5-Fluorouracil in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Chuntao Gao, Professor (022-2340123 ext. 3077, gaochuntao@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: 4 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 NCT06259058.

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 15 Mar 2024.

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