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N/A N=96 Randomized Triple-blind Treatment

Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer

Treatment

Enrolled (actual)
96
Serious AEs
42.7%
Results posted
Dec 2025
Primary outcome: Primary: 1-year Progression Free Survival Rate — 9; 18 Participants

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

OutcomeResultp-value
PRIMARY
1-year Progression Free Survival Rate
9; 18
SECONDARY
Treatment-related Adverse Events
45; 46
SECONDARY
Progression Free Survival
7.3; 9.6
SECONDARY
Overall Survival
10.8; 15.2

Summary

The purpose of this study is to compare the efficacy and safety of a recurrence-pattern-based-volume versus conventional-volume stereotactic body radiation therapy for locally advanced pancreatic cancer, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.

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, chemotherapy, 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04699539). 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.

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