Radiotherapy with GX regimen after high-risk pancreatic cancer surgery

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 phase 3 trial investigates the use of radiotherapy combined with a GX chemotherapy regimen as adjuvant treatment after pancreatic cancer surgery in patients with high-risk features. Eligible participants are adults up to 75 years old with histologically confirmed pancreatic ductal adenocarcinoma and no distant metastasis who have undergone R1/R2 or other high-risk factors postoperatively. The study compares the GX plus radiotherapy approach to the standard post-surgical care, aiming to improve local control and overall survival. Comprehensive eligibility criteria ensure adequate organ function and recovery after surgery before starting treatment. The trial is conducted at Tianjin Medical University Cancer Institute and Hospital in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin medical university hospital and institute
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Maobin Meng
• Email: mmeng@tmu.edu.cn
• Phone: 022-23340123-1111

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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.