This is a prospective, single-center, single-arm, phase II clinical study. The primary purpose of the study was to evaluate the efficacy and safety of radiotherapy with sequential albumin-bound paclitaxel + Gemcitabine chemotherapy + anti-PD-1 monoclonal antibody and Thymalfasin for borderline resectable pancreatic cancer, and to explore clinical indicators related to efficacy, further guiding subsequent individualized precise treatment.
Age ≥ 18 years, with ECOG score of 0 ~ 1;
Histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of pancreas;
Classification as borderline resectable pancreatic cancer according to the NCCN Guidelines (2024 Edition);
Deemed suitable for neoadjuvant therapy following discussion by the MDT team of the study site;
Prior systemic anti-tumor therapy;
Prior medical history of other tumors, except for cervical carcinoma in situ, treated squamous cell carcinoma or urothelial bladder carcinoma (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years prior to enrollment);
Prior history of abdominal radiotherapy;
Subjects with active bacterial or fungal infection (≥ Grade 2 as per NCI-CTC, Version 3).
Single group
SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin
Combination productStereotactic body radiation therapy (SBRT): 30 \~ 40 Gy/5f, Week 1, Day 1 \~ Day 5, 6-8 Gy/time, once a day; 3 weeks as a cycle, for 4 cycles Tislelizumab: 200 mg, i.v., single infusion, 21 days as a cycle for 4 cycles, on Day 1 of each treatment cycle; Thymalfasin: 4.8 mg, subcutaneous injection, twice a week, on Day 1 and Day 4 of each week during Weeks 1 \~ 13; Albumin-bound paclitaxel: 125 mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; Gemcitabine: 1000mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; After 4 cycles of preoperative neoadjuvant therapy, radical surgery will be evaluated by the MDT team within 2-4 weeks after completion of chemotherapy + immunotherapy.
R0 resection rate
Defined as the proportion of patients in the ITT population who undergo R0 resection following neoadjuvant therapy among patients undergoing surgery.
Tumor regression grade (TRG)
Tumor regression grade was determined according to the postoperative pathological results.
Pathologic complete response (pCR) rate
Defined as the proportion of patients in the ITT population who reach pT0N0M0 among patients undergoing surgery.
Median progression-free survival (mPFS)
The median time from the first dose to any documented tumor progression or death due to any cause (whichever occurs first) in the ITT population. Patients who are alive at the time of analysis and have no documented disease progression will be reviewed on the date of the last imaging assessment.
Median overall survival (mOS)
The median time from the first dose to death due to any cause in the ITT population. Patients who are alive at the time of analysis will be reviewed on their last contact date.
The expression of CD68
The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC
The expression of CD86
The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC
The expression of CD163
The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC
The expression of CD4
The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC
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