Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer: A Multi-center, Randomized Controlled Phase II Clinical Trial
This is a Phase II, multicenter, randomized controlled trial to assess the efficacy of Stereotactic Body Radiotherapy (SBRT) in combination with maintenance therapy in patients with advanced pancreatic cancer. The aim is to compare the efficacy of SBRT combined with maintenance therapy versus maintenance therapy alone. The primary outcome is the overall survival (OS) of patients, with secondary endpoints including progression-free survival (PFS), response rates, and quality of life assessments. The study will involve patients with unresectable pancreatic adenocarcinoma who are receiving chemotherapy and have stable disease. The hypothesis is that SBRT, by improving local control, can enhance the benefit of ongoing maintenance therapy and lead to better overall survival outcomes in this patient group.
• Age 18 to 70 years old.
• Histologically or cytologically confirmed diagnosis of pancreatic - adenocarcinoma.
• No prior radiation therapy for pancreatic cancer.
• At least one measurable lesion of the primary pancreatic tumor as per RECIST 1.1 criteria, eligible for SBRT.
• Completion of first-line chemotherapy with stable disease (SD) or partial response (PR) after ≥4 months of treatment.
• ECOG performance status of 0-2.
• Expected survival of ≥3 months.
• Adequate organ function within 14 days prior to enrollment:
• Hemoglobin (Hb) ≥ 90 g/L
• Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L
• Platelets (PLT) ≥ 75×10⁹/L
• Total bilirubin ≤ 1.5× ULN or direct bilirubin ≤ ULN
• ALT/AST ≤ 2.5× ULN
• ALP ≤ 2.5× ULN
• Serum creatinine ≤ 1.5× ULN or calculated creatinine clearance ≥ 40 mL/min
• Urine protein \< 2+ (if ≥2+ on dipstick, 24-hour urine protein must be \< 2g)
• No use of systemic corticosteroids in the last 7 days prior to enrollment (physiological corticosteroid replacement is allowed).
• Women of childbearing potential and men must use effective contraception during the study and for 12 months following treatment completion.
• Voluntary participation with signed informed consent.
• Ability to comply with the study schedule.