N/A
N=119
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
Treatment
Bottom Line
View on ClinicalTrials.gov: NCT04603586 ↗Enrolled (actual)
119
Serious AEs
42.9%
Results posted
Oct 2025
Primary outcome: Primary: Progression-Free-Survival — 8.6; 11.3 month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SBRT (Radiation); Chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Changhai Hospital
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free-Survival |
8.6; 11.3 | — |
| SECONDARY Adverse Events |
58; 57 | — |
| SECONDARY Overall Survival |
12.2; 17.2 | — |
Summary
The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) ( 70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.
Eligibility Criteria
Inclusion Criteria
- Cytologically or histologically verified pancreatic adenocarcinoma
- Imaging examinations confirmed locally advanced pancreatic cancer
- No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy
- ECOG of 0 to1
- Age of 18 years or older
- Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) ≥ 1.5×10^9 cells/L, leukocyte count≥ 3.5×10^9 cells/L, platelets ≥ 70×10^9 cells/L, hemoglobin ≥ 8.0 g/dl
- Adequate liver and renal, defined as: Albumin > 2.5 g/dL, total bilirubin < 3 mg/dL, creatinine < 2.0 mg/dL, AST<2.5 × ULN (Upper Limit of Normal) (0-64U/L), ALT<2.5 × ULN (0-64U/L)
- Adequate blood clotting function, defined as: international normalized ratio (INR) < 2 (0.9-1.1)
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Previously receiving radiotherapy, immunotherapy or targeted therapy
- Evidences of metastatic disease confirmed by chest CT or PET-CT
- ECOG ≥2
- Age <18 years
- Secondary malignancy
- Abnormal results of blood routine examinations and liver and kidney and coagulation tests
- Patients with active inflammatory bowel diseases or peptic ulcer
- Gastrointestinal bleeding or perforation within 6 months
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Medical history of symptomatic congestive heart failure: New York Heart Association Class III to IV
- Medical history of respiratory insufficiency
- Women who are pregnant or breastfeeding
- Participation in another clinical treatment trial
- Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Data sourced from ClinicalTrials.gov (NCT04603586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.