This study intends to explore conversion therapy for locally advanced pancreatic cancer (LAPC). The intervention starts with modified stereotactic body radiation therapy (3-day regimen), followed by systemic therapy within 1-2 weeks after irradiation. Subsequently, the investigator will evaluate the resectability of the lesion. For subjects converted to resectable status, surgical resection will be performed, followed by postoperative adjuvant therapy. For subjects who remain unresectable but maintain stable disease, a second cycle of conversion therapy will be continued. If the lesion is converted to resectable, surgical resection will be performed followed by adjuvant therapy. If disease progression occurs, subsequent treatment will be carried out in accordance with the first-line treatment for advanced pancreatic cancer. For subjects who experience disease progression or distant metastasis, subsequent treatment will be administered by adjusting the chemotherapy regimen in accordance with the first-line standard regimen for advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
20 mg/kg, intravenous infusion, administered on Day 1, every 3 weeks as one cycle (Q3W)
Oxaliplatin: 60 mg/m², intravenous infusion over 2 hours, administered on Day 1 Irinotecan Liposome: 50 mg/m², intravenous infusion for more than 90 minutes, administered on Day 1 LV (Leucovorin): 400 mg/m², intravenous infusion over 2 hours, administered on Day 1 5-FU (5-Fluorouracil): 2400 mg/m², continuous intravenous infusion for 46 hours Every 3 weeks is defined as one treatment cycle (Q3W)
Target Volume Delineation: The gross tumor volume GTV1 is delineated on CT images. A 1 cm inward contraction from GTV1 is performed to generate GTV-lattice, within which small spherical volumes GTV-sbrt with a diameter of 1-1.5 cm are created, and the spacing between adjacent spheres is 3 times the sphere diameter. Prescription Fractionation: Simultaneous integrated boost radiotherapy is adopted, with the prescription dose: GTV-sbrt: 24 Gy in 3 fractions; GTV1: 9 Gy in 3 fractions.
surgical conversion rate
The proportion of patients who become eligible for surgery after treatment, relative to the total number of patients.
Time frame: 3 years
R0/R1 Resection Rate
The proportion of patients who achieve R0 (microscopically margin-negative) or R1 (microscopically margin-positive) resection among all patients who undergo surgery. R0 is defined as no residual tumor at the resection margin; R1 is defined as microscopic residual tumor at the resection margin.
Time frame: in 3 years
pCR
Pathological Complete Response: The absence of residual invasive tumor cells in the resected primary tumor specimen and/or lymph nodes upon pathological evaluation.
Time frame: in 3 years
MPR
Major Pathological Response: The presence of ≤10% viable residual tumor cells in the resected primary tumor specimen upon pathological evaluation.
Time frame: in 3 years
ORR
The proportion of patients who achieve a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST v1.1 (or other specified criteria) from the start of treatment until disease progression or initiation of subsequent anticancer therapy.
Time frame: in 3 years
EFS
The time from the date of treatment initiation to the date of first occurrence of any of the following events: disease progression that precludes surgery, local or distant recurrence, or death from any cause. Patients who are event-free at the time of data cutoff are censored at the date of their last disease assessmen
Time frame: in 3 years
OS
The time from the date of treatment initiation to the date of death from any cause. Patients who are alive at the time of data cutoff are censored at the date of last known follow-up.
Time frame: in 3 years
the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs)
Safety endpoints include the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: in 3 years
Immune Age Rejuvenation
Defined as a reduction in immune age of ≥3 years compared to the baseline measurement, as calculated by the immune age estimation model based on the data generated from the specified assay kit.
Time frame: in 3 years
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