SBRT plus maintenance therapy vs maintenance therapy alone in advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, multicenter, randomized trial enrolling adults with unresectable pancreatic adenocarcinoma who have stable disease after at least four months of first-line chemotherapy. Participants are randomized to receive stereotactic body radiotherapy (SBRT) in addition to maintenance chemotherapy or maintenance chemotherapy alone. Primary outcome is overall survival, with secondary measures including progression-free survival, response rates, and quality of life. SBRT aims to improve local tumor control while preserving quality of life and may enhance systemic therapy effects. The study seeks to determine if integrating SBRT can improve outcomes for this difficult-to-treat population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Jinbo Yue, Doctor
• Email: jbyue@sdfmu.edu.cn
• Phone: 0531-67626442

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.