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RECRUITING
NCT07632118
PHASE3

Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

Pancreatic cancer is a highly fatal malignant tumor. Simple surgical operations can no longer meet the treatment needs of pancreatic cancer patients. Postoperative adjuvant chemotherapy has a significant effect, which can effectively prevent or delay tumor recurrence and prolong the overall survival period of pancreatic cancer patients. Based on this, many guidelines both at home and abroad actively recommend that pancreatic cancer patients receive adjuvant chemotherapy after surgery (if there are no contraindications). Radiotherapy is one of the most commonly used local treatment methods. It can be used as a neoadjuvant or adjuvant therapy to increase the tumor resection rate or reduce the recurrence rate, or as a treatment approach for locally unresectable pancreatic cancer to improve local control. After complete gross resection of pancreatic cancer, the role of radioadjuvant therapy has always been controversial, and its indications for use remain unclear. However, recent clinical studies using modern radiotherapy equipment and techniques have shown that an increasing amount of data indicates that radiotherapy can benefit in the treatment of neoadjuvant, adjuvant and locally advanced pancreatic cancer. Evidence supporting adjuvant radiotherapy after pancreatectomy remains scarce. Therefore, whether screening high-risk factor populations for adjuvant radiotherapy may improve the prognosis of pancreatic cancer is an important research.

Official title: A Prospective, Multicenter, Randomized Controlled Phase III Study on Radiotherapy Combined With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2026-05-22

Completion Date

2031-05

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

RADIATION

Radiotherapy + GX

After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy. After concurrent chemoradiotherapy, continue with GX chemotherapy. Radiotherapy target and dose: Tumor bed, anastomosis, adjacent lymphatic drainage area :50 Gy; R1 resection area: 60 Gy; R2 resection area: 66-70 Gy (silver clip position), once daily.

DRUG

GX group

Gemcitabine (G): Intravenous infusion of 1000 mg/m2 for more than 30 minutes, administered on day 1 and day 8, repeated every 21 days. Capecitabine (X): 1660-2000mg/m2 per day, taken orally in two divided doses, from day 1 to day 14, repeated every 21 days as one cycle. Administration for 6 cycles, every 3 weeks .

Locations (1)

Tianjin medical university hospital and institute

Tianjin, Tianjin Municipality, China