PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRA… (NCT06345599) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study)
66 participantsStarted 2024-05-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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.
* ECOG score 0-1.
* Have at least 1 measurable lesion according to RECIST 1.1 criteria.
* No prior treatment with abdominal radiotherapy, chemotherapy and PD-1/PD-L1 antibody.
* Adequate organs functions as defined by the following laboratory values (completed within 14 days prior to registration): (1) haemoglobin \>= 90 g/L (no blood transfusion within 14 days); (2) neutrophil count \> 1.5x10\^9/L; (3) platelet count \>= 100x10\^9/L; (4) total bilirubin \<= 1.5xULN (upper limit of normal); (5) blood glutamic transferase (ALT) or blood glutamic transferase (AST) \<= 2.5xULN (6) endogenous creatinine clearance \>= 60 ml/min (Cockcroft's AST). (ALT) or blood albumin transaminase (AST) \<= 2.5xULN; (6) endogenous creatinine clearance \>= 60 ml/min (Cockcroft-Gault formula); (7) cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \>= 50%. (8) International normalised ratio (INR) of prothrombin time ≤ 1.5 and partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal in patients who have not received anticoagulation. Patients receiving full or par…
What they're measuring
1
Adverse events
Timeframe: 36 months
2
Serious adverse events
Timeframe: 36 months
3
1-year overall survival
Timeframe: The 1-year overall survival rate of patients after receiving treatment
Trial details
NCT IDNCT06345599
SponsorSecond Affiliated Hospital of Soochow University