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

19 mei 2026 bijgewerkt door: Jinbo Yue, Shandong Cancer Hospital and Institute

Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer: A Multi-center, Randomized Controlled Phase II Clinical Trial

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Pancreatic cancer is one of the most aggressive malignancies, and most patients are diagnosed at an advanced stage, making them ineligible for surgery. Despite systemic chemotherapy being the standard treatment for advanced pancreatic cancer, the prognosis remains poor, with median survival often less than one year. The addition of radiotherapy has shown some promise in improving outcomes, particularly in the setting of local control.

This Phase II, multicenter, randomized controlled trial evaluates the combination of Stereotactic Body Radiotherapy (SBRT) with maintenance therapy versus maintenance therapy alone in patients with advanced pancreatic cancer. SBRT offers a high dose of radiation with minimal damage to surrounding healthy tissues, potentially enhancing tumor control while preserving immune function, a key challenge in pancreatic cancer treatment. Moreover, SBRT has shown potential in stimulating anti-tumor immune responses, thus converting "cold" tumors into "hot" tumors that may respond better to subsequent therapies.

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, while the control group will receive maintenance chemotherapy alone. The chemotherapy regimen will be based on the patient's first-line treatment.

The study will evaluate the primary endpoint of one-year overall survival (OS) rate, alongside secondary endpoints including overall survival, progression-free survival (PFS), local control rate (LCR), and adverse event (AE) rates. In addition, exploratory endpoints include identifying potential biomarkers associated with the anti-tumor efficacy of SBRT and maintenance therapy. These biomarkers include PD-L1 expression, tumor mutational burden (TMB), and changes in immune cell subsets in blood and tumor tissue.

The results of this study will provide valuable insights into the combination of SBRT and maintenance chemotherapy as a potential treatment option for advanced pancreatic cancer, which may lead to improved survival outcomes and a better understanding of the biological mechanisms that drive treatment response.

Studietype

Ingrijpend

Inschrijving (Geschat)

24

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Werving
        • Shandong Cancer Hospital And Institute
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Age 18 to 70 years old.
  • Histologically or cytologically confirmed diagnosis of pancreatic - adenocarcinoma.
  • No prior radiation therapy for pancreatic cancer.
  • At least one measurable lesion of the primary pancreatic tumor as per RECIST 1.1 criteria, eligible for SBRT.
  • Completion of first-line chemotherapy with stable disease (SD) or partial response (PR) after ≥4 months of treatment.
  • ECOG performance status of 0-2.
  • Expected survival of ≥3 months.
  • Adequate organ function within 14 days prior to enrollment:
  • Hemoglobin (Hb) ≥ 90 g/L
  • Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L
  • Platelets (PLT) ≥ 75×10⁹/L
  • Total bilirubin ≤ 1.5× ULN or direct bilirubin ≤ ULN
  • ALT/AST ≤ 2.5× ULN
  • ALP ≤ 2.5× ULN
  • Serum creatinine ≤ 1.5× ULN or calculated creatinine clearance ≥ 40 mL/min
  • Urine protein < 2+ (if ≥2+ on dipstick, 24-hour urine protein must be < 2g)
  • No use of systemic corticosteroids in the last 7 days prior to enrollment (physiological corticosteroid replacement is allowed).
  • Women of childbearing potential and men must use effective contraception during the study and for 12 months following treatment completion.
  • Voluntary participation with signed informed consent.
  • Ability to comply with the study schedule.

Exclusion Criteria:

  • Currently participating in any interventional clinical trial or having received other investigational drugs or devices within 4 weeks prior to enrollment.
  • Peritoneal metastasis.
  • Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.
  • Receiving systemic corticosteroid treatment within 7 days prior to enrollment (except for physiological doses).
  • Active, untreated hepatitis B (HBsAg positive and detectable HBV-DNA) or active hepatitis C infection (HCV antibody positive and detectable HCV RNA).
  • Pregnant or breastfeeding women.
  • Any severe or uncontrolled systemic disease, including:
  • QTc interval ≥ 480 ms
  • Unstable angina
  • NYHA class III-IV congestive heart failure
  • Arterial thromboembolism (MI, unstable angina, stroke, TIA) within 6 months prior to enrollment
  • Uncontrolled hypertension (systolic BP ≥ 150 mmHg, diastolic BP ≥ 90 mmHg)
  • Active pulmonary tuberculosis, severe infections, or other uncontrolled diseases
  • Active gastrointestinal perforation, fistula, or bowel obstruction.
  • Inadequately controlled diabetes (fasting blood glucose > 10 mmol/L).
  • History of mental illness preventing compliance with treatment.
  • Active bleeding or significant coagulation abnormalities within the last 30 days.
  • Previous gastrointestinal perforation or other serious gastrointestinal conditions in the past 6 months.
  • Participation in other trials that may interfere with this study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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, the experimental group will receive SBRT in addition to maintenance chemotherapy
Straling: 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.
Experimenteel: 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, the control group will receive maintenance chemotherapy alone.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
1-Year Overall Survival (OS) Rate
Tijdsspanne: 12 months
The proportion of patients who are alive at 12 months from the start of the study.
12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: From the date of diagnosis until the date of death from any cause, whichever occurs first, assessed up to 24 months.
The time from diagnosis to death from any cause.
From the date of diagnosis until the date of death from any cause, whichever occurs first, assessed up to 24 months.
Progression-Free Survival (PFS)
Tijdsspanne: From the start of treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
The time from the start of treatment to disease progression or death.
From the start of treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Local Control Rate (LCR)
Tijdsspanne: Assessed at the end of treatment and at follow-up visits, up to 24 months.
The proportion of patients whose tumors are controlled at the primary site after treatment.
Assessed at the end of treatment and at follow-up visits, up to 24 months.
Adverse Event (AE) Rate
Tijdsspanne: Monitored throughout the treatment period, and safety follow-up will continue 30 days after the last dose or until the start of a new anti-cancer treatment, whichever occurs first
The frequency of all adverse events occurring during the treatment period.
Monitored throughout the treatment period, and safety follow-up will continue 30 days after the last dose or until the start of a new anti-cancer treatment, whichever occurs first

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shandong Cancer Hospital and Institute

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 augustus 2025

Primaire voltooiing (Geschat)

14 augustus 2028

Studie voltooiing (Geschat)

14 augustus 2028

Studieregistratiedata

Eerst ingediend

27 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 mei 2026

Eerst geplaatst (Werkelijk)

20 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

19 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SDZLEC2025-282-02

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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