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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
This 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.
GM-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
Adverse events
From the beginning of treatment, record the treatment-related toxic reactions that occur in patients.
Time frame: 36 months
Serious adverse events
From the start of treatment, record any severe adverse reactions that occur in the patient.
Time frame: 36 months
1-year overall survival
Record the 1-year overall survival rate of patients after receiving treatment
Time frame: 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.
Time frame: 36 months
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.
Time frame: 36 months
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.
Time frame: 36 months
R0 resection rate
The tumor was completely removed during surgery, and the resection margin was negative under microscopic observation.
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Albumin-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.
Time frame: 36 months
Progression free survival
The time between the start of treatment and the observation of disease progression or death for any reason. Patients who are still alive at the time of analysis will use the date of their last contact as the cutoff date.
Time frame: 36 months