PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study)

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Radiotherapy
  • Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab
  • Chemotherapy:Albumin-bound paclitaxel、Gemcitabine

Treatment groups

66 Participants
are divided into 1 treatment group

Locations

This trial has no locations