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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

January 10, 2027

Study Completion Date

January 10, 2027

Conditions
Pancreatic Ductal Adenocarcinoma
Interventions
RADIATION

Radiotherapy

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.

DRUG

Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab

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

DRUG

Chemotherapy:Albumin-bound paclitaxel、Gemcitabine

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.

All Listed Sponsors
lead

Second Affiliated Hospital of Soochow University

OTHER

NCT06345599 - PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study) | Biotech Hunter | Biotech Hunter