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Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer

NCT07600268 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-20

No results posted yet for this study

Summary

This is a Phase II, multicenter, randomized controlled trial to assess the efficacy of Stereotactic Body Radiotherapy (SBRT) in combination with maintenance therapy in patients with advanced pancreatic cancer. The aim is to compare the efficacy of SBRT combined with maintenance therapy versus maintenance therapy alone. The primary outcome is the overall survival (OS) of patients, with secondary endpoints including progression-free survival (PFS), response rates, and quality of life assessments. The study will involve patients with unresectable pancreatic adenocarcinoma who are receiving chemotherapy and have stable disease. The hypothesis is that SBRT, by improving local control, can enhance the benefit of ongoing maintenance therapy and lead to better overall survival outcomes in this patient group.

Conditions

  • Pancreatic Cancer Non-resectable

Interventions

RADIATION

Stereotactic Body Radiotherapy (SBRT) with maintenance therapy

Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria. After completion of the chemotherapy, they will be randomized into two groups: the experimental group will receive SBRT in addition to maintenance chemotherapy. The chemotherapy regimen will be based on the patient's first-line treatment.

DRUG

Maintenance therapy

Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria. After completion of the chemotherapy, they will be randomized into two groups: the control group will receive maintenance chemotherapy alone. The chemotherapy regimen will be based on the patient's first-line treatment.

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2028-08-14
Completion
2028-08-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07600268 on ClinicalTrials.gov