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

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.

Eligibility

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.

Conditions2

Interventions1

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