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2025-10-01
2028-10-01
2028-12-31
42
NCT07173387
Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute
INTERVENTIONAL
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial
This prospective, multicenter clinical study evaluates the efficacy and safety of NALIRIFOX in combination with Stereotactic Body Radiation Therapy (SBRT) for patients with locally advanced unresectable pancreatic cancer. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety assessment. The study involves two cohorts: Cohort 1 (early SBRT after 1 cycle of NALIRIFOX) and Cohort 2 (late SBRT after 6-8 cycles of NALIRIFOX). A total of 42 participants are expected to be enrolled, with a follow-up period of at least 24 months. This trial aims to provide a novel therapeutic option for this patient population.
The study will assess the combination of NALIRIFOX (a chemotherapy regimen including liposomal irinotecan) and SBRT in patients with locally advanced unresectable pancreatic cancer. NALIRIFOX consists of liposomal irinotecan, oxaliplatin, 5-FU, and leucovorin, administered in 10-12 cycles every two weeks. SBRT will be applied after a variable period of chemotherapy, randomzing either early or late in the treatment course. The study's main endpoint is progression-free survival (PFS), which is the time from the start of treatment to disease progression or death. Secondary endpoints include ORR, DCR, and OS, providing a comprehensive evaluation of the treatment's effectiveness. Furthermore, the safety profile of the combination will be evaluated, focusing on adverse events using the NCI-CTCAE version 5.0. A total of 42 patients will be enrolled, with an expected follow-up duration of 24 months. The study is designed to explore whether this combined modality can improve outcomes for patients.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-09-08 | N/A | 2025-09-08 |
2025-09-08 | N/A | 2025-09-15 |
2025-09-15 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Early SBRT after NALIRIFOX Treatment Participants in this arm will receive 1 cycle of NALIRIFOX followed by early SBRT. NALIRIFOX will be continued for up to 10-12 cycles after the completion of SBRT. | DRUG: NALIRIFOX (liposomal irinotecan-based chemotherapy).
RADIATION: Stereotactic Body Radiation Therapy (SBRT).
|
| EXPERIMENTAL: Late SBRT after NALIRIFOX Treatment Participants in this arm will receive 6-8 cycles of NALIRIFOX followed by late SBRT. NALIRIFOX will be continued for up to 10-12 cycles after the completion of SBRT. | DRUG: NALIRIFOX (liposomal irinotecan-based chemotherapy).
RADIATION: Stereotactic Body Radiation Therapy (SBRT).
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The primary outcome measure is progression-free survival (PFS), which is defined as the time from the start of treatment to the first occurrence of disease progression or death. | Up to 24 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate | Defined as the percentage of patients who achieve a partial or complete response, measured by tumor shrinkage using RECIST 1.1 criteria. | up to 24 months. |
| Disease Control Rate | Defined as the percentage of patients who achieve a complete response, partial response, or stable disease. | up to 24 months. |
| Overall Survival | Defined as the time from the start of treatment to death from any cause. | up to 24 months. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jinbo Yue, Doctor Phone Number: 0531-67626442 Email: jbyue@sdfmu.edu.cn |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
