Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06840067
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.
Sponsor:
Gansu Wuwei Tumor Hospital
Organization:
Study Overview
Official Title:
Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer.
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: