NCT05424159 Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer
| NCT ID | NCT05424159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Proton and Heavy Ion Center |
| Condition | Pancreatic Cancer Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2022-07-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.
Eligibility Criteria
Inclusion Criteria: 1. Have the ability to sign the written informed consent; 2. Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology; 3. Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC/UICC Version 8); 4. The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm; 5. Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine); 6. Eastern Cooperative Oncology Group (ECOG) performance score 0-1; 7. Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL); 8. Adequate liver function (total bilirubin \<1.5 times the upper limit of normal value, aminotransferase \<2.5 times the upper limit of normal value); 9. Adequate renal function (serum creatinine \<2mg/dL, or creatinine clearance \>50mL/min). Exclusion Criteria: 1. Multiple primary pancreatic lesions (\>1); 2. Tumor invaded the adjacent digestive tract; 3. Radiation therapy history; 4. Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation; 5. The irradiation dose of organs at risk cannot reach the dose constraint; 6. Other malignant tumors history; 7. Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.
Contact & Investigator
Zheng Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Shanghai Proton and Heavy Ion Center
Frequently Asked Questions
Who can join the NCT05424159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pancreatic Cancer Non-resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05424159 currently recruiting?
Yes, NCT05424159 is actively recruiting participants. Contact the research team at zheng.wang@sphic.org.cn for enrollment information.
Where is the NCT05424159 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05424159 clinical trial?
NCT05424159 is sponsored by Shanghai Proton and Heavy Ion Center. The principal investigator is Zheng Wang, MD, PhD at Shanghai Proton and Heavy Ion Center. The trial plans to enroll 48 participants.
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