Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

19 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

24

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Shandong
      • Jinan, Shandong, Chine, 250021
        • Recrutement
        • Shandong Cancer Hospital And Institute
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
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.
Expérimental: 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
1-Year Overall Survival (OS) Rate
Délai: 12 months
The proportion of patients who are alive at 12 months from the start of the study.
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shandong Cancer Hospital and Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 août 2025

Achèvement primaire (Estimé)

14 août 2028

Achèvement de l'étude (Estimé)

14 août 2028

Dates d'inscription aux études

Première soumission

27 avril 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

20 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SDZLEC2025-282-02

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner