Status:
NOT_YET_RECRUITING
Stereotactic Centralized Ablative Radiotherapy for Locally Advanced Pancreatic Cancer: A Single-Arm Phase I Safety and Feasibility Study
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Pancreatic Cancer
Locally Advanced Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a single-arm, phase I clinical study designed to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) dose escalation in patients with locally adv...
Detailed Description
Pancreatic cancer is among the most aggressive malignancies and is associated with poor prognosis. The 5-year survival rate remains below 10%, and most patients present with unresectable disease at di...
Eligibility Criteria
Inclusion
- \- Age 18-70 years, male or female. Histologically or cytologically confirmed diagnosis of pancreatic cancer. Locally advanced, unresectable disease without evidence of distant metastasis (based on imaging such as CT/MRI/PET-CT).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Adequate bone marrow, liver, and renal function (per laboratory criteria). Life expectancy ≥ 3 months. Signed written informed consent prior to participation.
Exclusion
- \- Evidence of distant metastasis. Prior abdominal radiotherapy. Prior systemic chemotherapy or immunotherapy within 4 weeks before enrollment. Concurrent participation in another interventional clinical trial. Severe comorbidities (e.g., uncontrolled cardiovascular, pulmonary, or infectious diseases).
- Pregnant or breastfeeding women. Known history of other malignancies within the past 5 years (except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ).
- Any condition that, in the investigator's judgment, would interfere with patient safety or compliance with the study protocol.
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07173374
Start Date
September 10 2025
End Date
September 1 2028
Last Update
September 15 2025
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531