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NOT YET RECRUITING
NCT07827053
PHASE2

Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

This study intends to explore conversion therapy for locally advanced pancreatic cancer (LAPC). The intervention starts with modified stereotactic body radiation therapy (3-day regimen), followed by systemic therapy within 1-2 weeks after irradiation. Subsequently, the investigator will evaluate the resectability of the lesion. For subjects converted to resectable status, surgical resection will be performed, followed by postoperative adjuvant therapy. For subjects who remain unresectable but maintain stable disease, a second cycle of conversion therapy will be continued. If the lesion is converted to resectable, surgical resection will be performed followed by adjuvant therapy. If disease progression occurs, subsequent treatment will be carried out in accordance with the first-line treatment for advanced pancreatic cancer. For subjects who experience disease progression or distant metastasis, subsequent treatment will be administered by adjusting the chemotherapy regimen in accordance with the first-line standard regimen for advanced pancreatic cancer.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-09-01

Completion Date

2030-09-01

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

Adebrelimab (PD-L1 inhibitor)

20 mg/kg, intravenous infusion, administered on Day 1, every 3 weeks as one cycle (Q3W)

DRUG

NALIRIFOX

Oxaliplatin: 60 mg/m², intravenous infusion over 2 hours, administered on Day 1 Irinotecan Liposome: 50 mg/m², intravenous infusion for more than 90 minutes, administered on Day 1 LV (Leucovorin): 400 mg/m², intravenous infusion over 2 hours, administered on Day 1 5-FU (5-Fluorouracil): 2400 mg/m², continuous intravenous infusion for 46 hours Every 3 weeks is defined as one treatment cycle (Q3W)

RADIATION

SBRT

Target Volume Delineation: The gross tumor volume GTV1 is delineated on CT images. A 1 cm inward contraction from GTV1 is performed to generate GTV-lattice, within which small spherical volumes GTV-sbrt with a diameter of 1-1.5 cm are created, and the spacing between adjacent spheres is 3 times the sphere diameter. Prescription Fractionation: Simultaneous integrated boost radiotherapy is adopted, with the prescription dose: GTV-sbrt: 24 Gy in 3 fractions; GTV1: 9 Gy in 3 fractions.