A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.
Obtain written informed consent before implementing any trial-related procedures;
Age ≥ 18 years and ≤ 75 years, gender not specified;
Pancreatic cancer confirmed by histopathology examination;
Locally advanced pancreatic ductal adenocarcinoma and no prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received;
Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first administration (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection);
Is currently participating in an interventional clinical study or has received other study medication or used the study device within 4 weeks prior to the first dose;
Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs directed against another stimulatory or synergistic T cell receptor suppressor (e.g., CTLA-4, OX-40, CD137);
Systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control ascites) within 2 weeks before the first administration;
Single group
Cadonilimab
Drug10mg/kg，IV，D1，Q3W
Gemcitabine
Drug1000mg/m2，IV，D1、D8、D15，Q4W
Nab-Paclitaxel
Drug125mg/m2，IV，D1、D8、D15，Q4W
Clinical benefit rate (CBR, CR+PR+SD)
Clinical benefit rate ( complete response and partial response and stable disease)
ORR
overall response rate
PCR
Complete pathological response rate
(EFS)RECIST 1.1
event free survival
OS
Overall survival .OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
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