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

March 14, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2
  • Phase 1

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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]).
  • 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.

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: NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOX
Patients 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.
Drug: Irinotecan liposome injection
50 mg/m² on Day 1 of a 14-day cycle
Other Names:
  • Nal-IRI
Drug: Oxaliplatin
60 mg/m² on Day 1 of a 14-day cycle
Other Names:
  • Eloxatin
Drug: 5-Fluorouracil
2400 mg/m² continuous IV infusion in 46 h
Other Names:
  • 5-FU
  • Adrucil
  • flurouracil
Drug: Leucovorin
400 mg/m² on Day 1 of a 14-day cycle
Other Names:
  • Folinic Acid
Radiation: SBRT
30Gy/5Fx
Active Comparator: NALIRIFOX + Surgery + NALIRIFOX
Patients 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.
Drug: Irinotecan liposome injection
50 mg/m² on Day 1 of a 14-day cycle
Other Names:
  • Nal-IRI
Drug: Oxaliplatin
60 mg/m² on Day 1 of a 14-day cycle
Other Names:
  • Eloxatin
Drug: 5-Fluorouracil
2400 mg/m² continuous IV infusion in 46 h
Other Names:
  • 5-FU
  • Adrucil
  • flurouracil
Drug: Leucovorin
400 mg/m² on Day 1 of a 14-day cycle
Other Names:
  • Folinic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 4 months
Defined as the proportion of patients who have achieved R0 resection.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 7 months
Use NCI-CTCAE version 5.0 for classification and grading.
7 months
Overall survival
Time Frame: 2 years
Defined as the time between signing the informed consent form and death due to various causes.
2 years
Objective Response Rate
Time Frame: 3 months
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1
3 months
Surgical Conversion Rate (R0 / R1 resection)
Time Frame: 4 months
Defined as the percentage of patients that underwent a R0/R1 resection.
4 months
Tumor regression grade
Time Frame: 4 months
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.
4 months
Event-free Survival
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Jihui Hao, Professor, Tianjin Medical University Cancer Institute and 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DEY-PC-K04

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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