New radiation approach targets inoperable pancreatic tumors
NCT ID NCT03403049
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new type of radiation called carbon ion therapy for people with locally advanced pancreatic cancer that cannot be removed by surgery. Fourteen participants received increasing doses of carbon ion radiation along with chemotherapy. The main goal was to find the highest safe dose that doesn't cause severe side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- carbon ion radiation therapy
- What this could lead to
- If successful, this could establish a safer radiation dose for treating inoperable pancreatic cancer, potentially improving tumor control.
- What could go wrong
- This is a very early, small Phase I trial with only 14 participants, focused on safety, not effectiveness. The treatment may still cause severe side effects or fail to shrink tumors.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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14 people
The number who actually took part.
- Started
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Apr 2016
- Finished
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Jul 2019
- 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 99 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: 1. Signed the informed consent form; 2. Age ≥ 18; 3. Capable of following the protocol 4. Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas; 5. Unresectable adenocarcinoma of the pancreas by radiographic criteria according to the criteria of the NCCN Guidelines and based on post-chemotherapy imaging or due to medical contraindications to radical resection; 6. No evidence of distant metastases based on imaging evaluation; 7. Maximum tumor and positive lymph node diameter ≤ 6 cm; 8. ECOG Performance Status 0-1; 9. Life expectancy ≥ 12 weeks; 10. Adequate blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥9 g/dL (use of transfusion to achieve said levels or greater is acceptable); 11. Adequate liver function: total bilirubin \<1.5 x ULN, and AST and ALT \<2.5 x ULN; 12. Adequate kidney function: serum creatinine ≤1.25 x ULN or calculated creatinine clearance rate ≥50mL/min and urine protein \<2+.If the patient's baseline urine protein is at ≥2+, urine samples must be taken for 24 hours to verify that urine protein is ≤1g; 13. Laboratory studies within 14 days prior to registration demonstrating that the internationalization standard ratio (INR) ≤1.5 and prothrombin time (PPT) ≤1.5 x ULN. 14. Prior receipt of 2-4 cycles of Gemcitabine-based systemic chemotherapy. Exclusion Criteria: 1. Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation; 2. ECOG Performance Status \>=2; 3. Poor liver, kidney and bone marrow function that do not meet the requirements for treatment; 4. Persistent grade ≥ 2 toxicity due to previous cancer treatment; 5. Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation; 6. Those wearing a cardiac pacemaker or another type of metal prosthetic implant whose normal functions may suffer interference from high energy radiation or that could affect the radiation target area; 7. Where it is not possible to achieve the predetermined safety dose limit with the dose equivalent limit of the organ at risk such as the liver or digestive tract, etc.; 8. If the doctor determines that the heavy proton or carbon ion dosage radiotherapy will not bring any benefit to the patient; 9. Patients suffering from another illness or other factors that could affect the proton or carbon ion therapy; 10. Pregnant (verified by serum or urine β-HCG test) or breastfeeding females; 11. Drug-abuse or alcohol dependency; 12. HIV positive, including those that have received antiretroviral therapy; replicative stage of chronic Hepatitis B virus; active stage of Hepatitis C; and active stage of syphilis; 13. HBV positive patients suffering from replicative stage of hepatitis virus, requiring antiretroviral therapy but cannot due to a concomitant disease; 14. Patients with a history of mental illness that may prevent their completion of treatment; 15. Patients with serious complications that could affect the course of treatment, including: * Unstable angina, congestive heart failure, or myocardial infarction requiring hospital admittance over the last 6 months; * Acute or systemic bacterial infection; * Chronic exacerbated obstructive pulmonary disease or other respiratory system disease requiring inpatient treatment; * Impaired liver function or impaired kidney function; * Patients suffering from immunosuppression; 16. Patients with contraindications to receiving radiotherapy, such as a serious connective tissue disease (eg: scleroderma) 17. Patients that are unable to understand the objective of the treatment/cannot sign the informed consent form; 18. Patients that lack civil capacity to act or whose civil capacity to act is limited.
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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.
Contacts and locations
Locations
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Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
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Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
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