Actively Recruiting
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
Led by Shandong Cancer Hospital and Institute · Updated on 2026-05-20
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness of combining Stereotactic Body Radiotherapy (SBRT) with maintenance therapy compared to maintenance therapy alone in patients with advanced pancreatic cancer. This Phase II multicenter randomized controlled trial focuses on patients diagnosed with unresectable pancreatic adenocarcinoma who have stable disease after chemotherapy. The goal is to determine if SBRT can improve local tumor control and thus enhance overall survival outcomes in this group. Participants will be randomly assigned to one of two groups after completing at least four months of first-line chemotherapy with stable disease or partial response. One group will receive SBRT alongside maintenance chemotherapy, while the other will continue with maintenance chemotherapy alone. The chemotherapy regimen will be based on each patient's initial treatment. SBRT delivers high doses of radiation precisely to the tumor, aiming to minimize harm to surrounding healthy tissues and potentially stimulate immune responses. During the study, participants will undergo evaluations of survival rates, disease progression, tumor control, and any adverse events. The primary outcome is the one-year overall survival rate, with secondary outcomes including overall survival up to 24 months, progression-free survival, local control rate, and safety monitoring throughout treatment and 30 days after the last dose. Researchers will also explore biomarkers related to treatment response. Participation involves regular follow-ups and assessments to track these outcomes until study completion.
CONDITIONS
Brief Title
Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- No prior radiation therapy for pancreatic cancer
- At least one measurable primary pancreatic tumor lesion eligible for SBRT
- Completed at least four months of first-line chemotherapy with stable disease or partial response
- ECOG performance status of 0 to 2
- Expected survival of at least 3 months
- Adequate organ function within 14 days prior to enrollment including hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.5×10⁹/L, platelets ≥ 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 creatinine clearance ≥ 40 mL/min, urine protein < 2+
- No systemic corticosteroids used within 7 days before enrollment (except physiological replacement)
- Women and men must use effective contraception during the study and 12 months after treatment
- Voluntary participation with signed informed consent
- Ability to comply with the study schedule
You will not qualify if you...
- Currently in another interventional clinical trial or received investigational drugs/devices within 4 weeks
- Presence of peritoneal metastasis
- Active central nervous system metastasis or carcinomatous meningitis
- Systemic corticosteroid treatment within 7 days before enrollment (except physiological doses)
- Active untreated hepatitis B or C infection
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic diseases including QTc interval ≥ 480 ms, unstable angina, advanced heart failure, recent arterial thromboembolism, uncontrolled hypertension, active tuberculosis or severe infections
- Active gastrointestinal perforation, fistula, or bowel obstruction
- Poorly controlled diabetes (fasting glucose > 10 mmol/L)
- History of mental illness preventing treatment compliance
- Active bleeding or significant coagulation problems in the past 30 days
- Previous serious gastrointestinal conditions in the past 6 months
- Participation in other trials that might interfere with this study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or discontinuation
Participants receive either Stereotactic Body Radiotherapy (SBRT) combined with maintenance chemotherapy or maintenance chemotherapy alone, based on their randomization group after completing first-line chemotherapy.
Visits scheduled according to treatment cycles; exact frequency varies by chemotherapy regimen and SBRT sessions
Duration - Up to 24 months after treatment
Participants are monitored for overall survival, progression-free survival, local tumor control, and adverse events after treatment ends.
Approximately monthly visits during follow-up period
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250021
Actively Recruiting
Research Team
J
Jinbo Yue, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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