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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer Non-resectable
• Intervention / Treatment: Radiation: Stereotactic Body Radiotherapy (SBRT) with maintenance therapy; Drug: Maintenance therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinbo Yue, Doctor; Phone Number: 0531-67626442; Email: jbyue@sdfmu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Cancer Hospital and Institute
      • Contact: Jinbo Yue, Doctor; Email: jbyue@sdfmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Experimental: 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 control group will receive maintenance chemotherapy alone. The chemotherapy regimen will be based on the patient's first-line treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-Year Overall Survival (OS) Rate	The proportion of patients who are alive at 12 months from the start of the study.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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)	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)	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	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

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2025
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): August 14, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chemotherapy; Pancreatic cancer; Stereotactic Body Radiotherapy; maintenance therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Health Care Facilities Workforce and Services; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery; Maintenance
• Other Study ID Numbers: SDZLEC2025-282-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No