Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in Locally Advanced Pancreatic Cancer
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of concurrent radiotherapy with envafolimab and capecitabine in locally advanced pancreatic cancer.Eligibility patients will receive intensity-modulated radiotherapy(IMRT)or volumetric modulated arc therapy(VMAT) to pancreatic lesions,metastatic lymph nodes and high-risk lymphatic drainage areas,concurrent with and followed by envafolimab and capecitabine.
• Age: 18-90 years old.
• Pancreatic cancer diagnosed by histology or cytology.
• Locally or regionally advanced non-resectable pancreatic cancer without systemic metastases other than retroperitoneal lymph nodes.
• Patients who have not received prior systemic chemotherapy or who have progressed on first-line therapy.
• At least one measurable lesion (≥10 mm long diameter on CT scan for tumor lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria).
• ECOG score: 0-1.
• Expected survival ≥ 3 months.
• Normal function of major organs, meeting the following criteria:
• Criteria for routine blood tests need to be met (no blood and blood products transfusion within 14 days):
∙ ANC ≥ 1.5×10\^9/L
‣ PLT ≥80×10\^9/L
⁃ Biochemical tests need to meet the following criteria:
• TBIL\<1.5 ULN
∙ ALT and AST \< 2.5ULN and in patients with liver metastases \< 5ULN
∙ Serum Cr ≤ 1.25ULN or endogenous creatinine clearance \> 45 ml/min (Cockcroft-Gault formula) 11).Subjects voluntarily enrolled in this study and signed an informed consent form, were compliant and cooperated with the follow-up.