A Phase 2 interventional study of Stereotactic Body Radiotherapy (SBRT) with maintenance therapy and Maintenance therapy in Pancreatic Cancer Non-resectable, sponsored by Shandong Cancer Hospital and Institute. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Shandong Cancer Hospital and Institute · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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, the control group will receive maintenance chemotherapy alone.
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 experimental group will receive SBRT in addition to maintenance chemotherapy. The chemotherapy regimen will be based on the patient's first-line treatment.
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.
1-Year Overall Survival (OS) Rate
The proportion of patients who are alive at 12 months from the start of the study.
Time frame: 12 months
Overall Survival (OS)
The time from diagnosis to death from any cause.
Time frame: 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)
The time from the start of treatment to disease progression or death.
Time frame: 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)
The proportion of patients whose tumors are controlled at the primary site after treatment.
Time frame: Assessed at the end of treatment and at follow-up visits, up to 24 months.
Adverse Event (AE) Rate
The frequency of all adverse events occurring during the treatment period.
Time frame: 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
Plan to share: No
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Shandong Cancer Hospital and Institute