Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.
ECOG PS 0-1
Pathological tissue-confirmed unresectable locally advanced pancreatic cancer
Pancreatic cancer patients who have not received systemic anti-tumor therapy
Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards
Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment
Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment
Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors
Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment
Single group
Sintilimab Plus mFFN or NALIRIFOX and Radiation
DrugSintilimab Plus mFFN or NALIRIFOX and Radiation
PFS
Time from first dose of study drug to first radiographic disease progression or death, whichever occurs first
AE
Advent event rate
Overal response rate
Proportion of subjects with complete response (CR) and partial response (PR) to total subjects; including assessment of irradiated lesions and non-irradiated lesions
Overall survival
The time from the start of treatment to death
Disease control rate
Proportion of total subjects defined as complete response (CR), partial response (PR), and stable disease (SD)
Duration of response
The time from when the tumor is first evaluated as CR or PR to when the tumor is first evaluated as PD (Progressive Disease) or death from any cause
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