Radiation boost may help control advanced pancreatic cancer
NCT ID NCT07600268
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether adding a precise, high-dose form of radiation (SBRT) to standard maintenance chemotherapy can help people with advanced pancreatic cancer live longer. The study enrolls 24 adults whose cancer has not grown after at least four months of initial chemo. Participants are randomly assigned to receive either maintenance chemo alone or maintenance chemo plus SBRT. The main goal is to see if the combination improves one-year survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic body radiotherapy (SBRT) plus maintenance chemotherapy
- What this could lead to
- If successful, this could offer a new way to extend survival for people with advanced pancreatic cancer by adding targeted radiation to standard maintenance therapy.
- What could go wrong
- This is a small, early-phase trial with only 24 participants, so results may not apply to everyone. The added radiation also carries risks like fatigue or digestive issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shandong Cancer Hospital and Institute
RECRUITINGJinan, Shandong, 250021, China
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