KEY POINTS
- This prospective, single-centre, open-label, nonrandomized trial enrolled 22 previously untreated patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma. Eleven patients were assigned to each cohort according to patient preference and multidisciplinary team decision.
- The stereotactic radiotherapy cohort received 25 Gy in 5 fractions, followed within one week by nab-paclitaxel, gemcitabine, and camrelizumab. The comparison cohort received the same chemoimmunotherapy without radiotherapy.
- The primary endpoint, objective response rate, was 36.4% in both cohorts; disease control was 100% in both. In the exploratory comparison, median progression-free survival was 12.5 versus 6.6 months with and without stereotactic radiotherapy (p=0.003), while median overall survival was 20.8 versus 13.9 months (p=0.261).
- Six patients (27.3%) underwent surgery, including four from the radiotherapy cohort and two from the comparison cohort. All six achieved clinical-to-pathologic downstaging and R0 resection.
- Grade 3–4 treatment-related adverse events occurred in 36.4% of each cohort. No grade 3 or higher acute luminal gastrointestinal toxicity occurred after stereotactic radiotherapy, and there were no treatment-related deaths.
CLINICAL TAKEAWAY
Early stereotactic body radiotherapy before nab-paclitaxel, gemcitabine, and camrelizumab produced an exploratory progression-free and locoregional-control signal without an apparent increase in severe toxicity. However, objective response was identical between cohorts, treatment allocation was nonrandomized, and the sample was small with baseline numerical imbalances, so the findings are preliminary rather than practice-changing.