New combo therapy aims to stop pancreatic cancer return after surgery
NCT ID NCT07632118
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding radiotherapy to standard chemotherapy after pancreatic cancer surgery can prevent the cancer from coming back. It enrolls 288 high-risk patients who have had surgery but still have factors like positive margins or lymph node involvement. Participants receive either chemotherapy alone or chemotherapy plus targeted radiation, and researchers track how long they stay cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiotherapy plus gemcitabine and capecitabine chemotherapy
- What this could lead to
- If successful, this could establish a new standard treatment to reduce recurrence and improve survival for high-risk pancreatic cancer patients after surgery.
- What could go wrong
- This is a mid-stage trial with 288 participants, so results may not apply to all patients. Radiotherapy can cause side effects like fatigue and digestive issues, and the benefit over chemotherapy alone is not yet proven.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 288 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2031
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 75 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: * Understand and voluntarily participate in this study and sign the informed consent form * Age ≥18 years old and ≤75 years old, male and female. * Confirmed as pancreatic ductal adenocarcinoma by histopathology or cytology, with no evidence of distant metastasis confirmed by imaging. * The preoperative neoadjuvant chemotherapy regimen is not limited and should not exceed 4 cycles. After the operation was completed, at least one postoperative high-risk factor was present :R1/R2 resection. Regional LN transfer Neurovascular invasion The pathology is poorly differentiated. Tumor height \>4cm; * No disease progression was evaluated by CT or MRI after the operation. * The subjects have sufficient organ and bone marrow functions: absolute neutrophil count ≥1.5×109, platelet count ≥80×109, hemoglobin ≥90g/L; Total bilirubin levels ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 times ULN. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 ml/min(Cockcroft-Gault formula); * ECOG PS score 0-1; * The expected postoperative survival period is ≥3 months; * Women of childbearing age who are not pregnant and have no pregnancy plans. Patients of childbearing age and their spouses are willing to take contraceptive measures that have been medically approved. Exclusion Criteria: * Had received radiotherapy, palliative chemotherapy or other targeted or immunotherapy for anti-tumor treatment before pancreatic tumor resection; * Suffering from severe underlying diseases, including but not limited to: active infections that require systemic medication treatment; Uncontrolled diabetes and hypertension; Negligent compensatory heart failure (NYHA grades III and IV), unstable angina, and acute myocardial infarction occurred within 3 months before enrollment. Malignant peritoneal effusion or pleural effusion; Severe portal hypertension or imaging manifestations of cavernous changes in the portal vein; Gastric outlet obstruction, respiratory insufficiency (requiring oxygen inhalation) and severe lung diseases; Central nervous system diseases, mental disorders; * There is a history of other malignant tumors (cured basal cell carcinoma of the skin and cervical carcinoma in situ) * There is bleeding or coagulation disorder; * Postoperative complications such as bleeding, pancreatic fistula, gastric emptying disorder, abdominal infection, and biliary fistula occur, which prevent the patient from receiving adjuvant treatment within 12 weeks after the operation. * Those who are allergic to the drugs or their components used in this plan; * Known to be infected with HIV or syphilis, or currently in the active stage of hepatitis (hepatitis B, hepatitis C); * Female subjects who are pregnant or breastfeeding, or plan to become pregnant during the study period, or female spouses of male subjects; * The subjects had poor compliance and were unable to follow the various procedures, restrictions or requirements of the study, etc. * There are other reasons that the researcher deems unsuitable for participation in 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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Tianjin medical university hospital and institute
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Other studies related to the condition(s) this trial covers.
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- Can a new radiation machine cut breath holds for cancer patients?