NCT06840067

Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.

Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Gansu Wuwei Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.

Detailed description

The objective is a single-center, single-arm, prospective Phase II clinical trial was conducted to evaluate the safety and efficacy of this regimen. The primary criteria for inclusion were 18 to 80 years of age, histologically or cytologically confirmed pancreatic ductal adenocarcinoma, and clinician assessment as inoperable or patient rejection of manual surgery. All eligible patients will receive CIRT in combination with gemcitabine and nituzumab. The primary endpoint of the study was progression-free survival (PFS). All patients included in the study were followed for survival for at least 12 months. A safe and effective segmentation dose for pancreatic cancer suitable for our facility and RBE model was obtained. The comprehensive treatment of carbon ion radiation therapy, targeted therapy and chemotherapy is effective of refractory tumors, radiation-resistant tumors, and complex tumors. Using the physical dosimetry and biological advantages of heavy ions, we can improve the tumor control rate and reduce the occurrence of surrounding normal tissue damage, and provide new treatment suggestions for locally advanced and metastatic pancreatic cancer.

Conditions

• Pancreatic Cancer Metastatic
• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
RADIATION	carbon ion radiotherapy (CIRT)	1.CIRT: GTV: Primary tumor visible on imaging and clinical examination, and involved regional lymph nodes identified by CT/MRI (≥1.0 cm) or PET/CT scan. CTV: GTV plus 5mm margin, include posterior peritoneal plexus area and elective node irradiation around the pancreas (ENI). PTV: CTV plus 2.5-5mm margin (depending on the system error of each unit; When pancreatic head cancer is close to the stomach and intestines, the gastrointestinal direction does not expand). ITV: delineated on 4D-CT considering the influence of respiratory activity. Prescription dose: Stratification by measuring the nearest distance between PTV and gastrointestinal tract (≥5mm or \< 5mm); Pancreatic head cancer (distance \< 5mm) : 52.8Gy(RBE)/4.4Gy/12Fx; Pancreatic head, body and tail cancer (≥5mm) : 57.2Gy(RBE)/4.4Gy/13Fx. CIRT was once a day, four or five times a week. 2.Chemotherapy:Gemcitabine 1000mg/m2, intravenous infusion, dl, d8; Q3w . 3.Targeted therapyNituzumab injection 400mg, Qw，at least 4-6 cycles.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-02-21
• Last updated: 2025-03-25

Locations

1 site across 1 country: China