The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer.
Age ≥ 18 ≤ 75 years；no gender limitations
Histopathologically and/or cytologically confirmed ductal adenocarcinoma of the pancreas, the patient has fresh pathological tissue and the tumour is located in the head and neck or body of the pancreas
Locally advanced pancreatic cancer, borderline resectable or unresectable, without metastases.
Life expectancy >= 3 months.
Pregnant or breastfeeding women
Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical cancer in situ.
Patients with a history of uncontrolled epilepsy, central nervous system disease or psychiatric disorders whose clinical severity, in the judgement of the investigator, may prevent the signing of informed consent or affect the patient's adherence to drug therapy.
Severe heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months.
Single group
Radiotherapy
RadiationThis study is a phase I clinical study. The study is divided into phases Ia and Ib. Phase Ia is a dose-escalation experiment, divided into two cohorts based on radiotherapy dose, with 3+3 patients per cohort for a total of 12 patients. The first group undergoes two cycles of radiotherapy: 24Gy:8Gy3f d4-d6. The second group undergoes one cycle of radiotherapy: 40Gy:8Gy5f d3-d7. Phase II consists of 40 patients who choose the radiotherapy dose based on the results of phase I.
Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab
DrugGM-CSF treatment: GM-CSF 200μg was started on the day of radiotherapy, and was subcutaneously injected daily for 7 consecutive days; d1-d7 Cadumilimab: use 375mg of cadumilimab within one week after radiotherapy
Chemotherapy:Albumin-bound paclitaxel、Gemcitabine
DrugAlbumin-bound paclitaxel 125mg/m2 d1, d8 Gemcitabine 1000mg/m2 d1, d8 After 3 cycles of neoadjuvant combination treatment with cadumilimab, the patient's surgical status will be evaluated. If surgery is possible, the patient will continue with another 3 cycles of treatment post-operation.
Adverse events
From the beginning of treatment, record the treatment-related toxic reactions that occur in patients.
Serious adverse events
From the start of treatment, record any severe adverse reactions that occur in the patient.
1-year overall survival
Record the 1-year overall survival rate of patients after receiving treatment
Objective response rate
The lesions were evaluated according to the RECIST1.1 standard, and the proportion of patients with the best treatment response of CR and PR after treatment to the total number of evaluable cases was calculated.
Disease control rate
The lesions were evaluated according to the RECIST1.1 standard, and the proportion of patients with optimal treatment response of CR, PR, and SD after treatment was calculated based on the total number of evaluable cases.
Overall survival
The time from the first day of enrollment to the occurrence of death due to any reason. Patients who are still alive at the time of analysis will use the date of their last contact as the deadline.
R0 resection rate
The tumor was completely removed during surgery, and the resection margin was negative under microscopic observation.
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