Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses

Last updated: September 29, 2025
Sponsor: Changhai Hospital
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Treatment

Chemotherapy

SBRT

Clinical Study ID

NCT04603586
Changhai Hospit
  • Ages > 18
  • All Genders

Study Summary

The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (<70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.

Eligibility Criteria

Inclusion

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 andthe willingness to sign a written informed consent document

Exclusion

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 coagulationtests

  • 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 AssociationClass 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 understandand the willingness to sign a written informed consent document

Study Design

Total Participants: 119
Treatment Group(s): 2
Primary Treatment: Chemotherapy
Phase:
Study Start date:
November 10, 2020
Estimated Completion Date:
August 15, 2025

Connect with a study center

  • Changhai hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Shanghai Changhai Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Changhai hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200433
    China

    Site Not Available

  • Shanghai Changhai Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200433
    China

    Site Not Available

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