Pancreatic adenocarcinoma
Conditions
Interventions
Experimental Group:The optimal dose of SCART is determined through dose escalation of SCART radiotherapy. Target area: GTV (primary pancreatic tumor) + 5mm edge ? CTV (considering respiratory motion),
The SCART area is located within the GTV, and the volume of the SCART is determined by the limit of the organs at risk. During the dose escalation stage, SCART was divided into four dose groups, namel
Sponsors
Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age range: 18-70 years old; 2. Pancreatic adenocarcinoma was confirmed by cytological or histopathological examination; 3. Has not received radiotherapy for pancreatic cancer in the past; 4. The primary lesion of pancreatic cancer should have at least one measurable lesion as stipulated in RECIST1.1 (the measurable lesion can accept SBRT); 5. Gastrointestinal endoscopy was performed within one month before enrollment to rule out active peptic ulcers. 6. The ECOG score is 0 to 1; 7. Life expectancy: 3 months or more; 8. Normal function of major organs (14 days before enrollment), that is, meeting the following criteria: The standard for blood routine examination should meet the following requirements: hemoglobin (HB) >=90g/L; Neutrophils (ANC) >=1.5×10^9/L; Platelet count (PLT) >=75×10^9/L; (2) No functional organic diseases, and the following standards must be met: Serum total bilirubin 1.5ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1 year)] must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, sexual desire control or barrier contraception combined with spermicides) during the trial. And continue contraception for 12 months after the treatment ends. Women of childbearing age need to take effective contraceptive measures. 11. Participation in this study is voluntary and an informed consent form must be signed. Participants should have a good degree of cooperation to cooperate with the follow-up, and they should understand the purpose of this study and the necessary procedures.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical research treatment, or having received other research drugs or used research devices for treatment within 4 weeks prior to enrollment; 2. Known active central nervous system (CNS) metastases and/or cancerous meningitis. 3. Have been receiving systemic glucocorticoid treatment (excluding nasal spray, inhalation or other forms of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before enrollment; Note: Physiological doses of glucocorticoids (prednisone or equivalent drugs =480 milliseconds; 2) Unstable angina pectoris, congestive heart failure with New York Heart Association (NYHA) classification III-IV; 3) Any arterial thrombosis, embolism or ischemia occurred within 6 months prior to enrollment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc. 4) Abnormal blood pressure control (systolic blood pressure =150mmHg, diastolic blood pressure >=90mmHg); 5) There was a history of non-infectious pneumonia requiring glucocorticoid treatment within one year before enrollment, or there was currently clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) There are active or uncontrolled infections that require systemic treatment; 8) There are clinical active diverticulitis, abdominal abscess and gastrointestinal obstruction. 9) Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L); 10) Those whose urine routine test indicates urine protein >=++ and whose 24-hour urine protein quantification is confirmed to be greater than 2.0g; 11) Patients with mental disorders who are unable to cooperate with treatment; 10. Within 30 days before enrollment, there was active bleeding, or a severe bleeding tendency or coagulation dysfunction, or the patient was receiving thrombolytic therapy. 11. Oral vitamin K antagonists are required for anticoagulant therapy. Low-dose warfarin (<=2 mg/ day) and other low-dose anticoagulants are allowed to be used to maintain the patency of central venous indwelling devices or to prevent deep vein thrombosis. Low-molecular-weight heparin treatment is permitted. 12. History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial colectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea; 13. Medical history or disease evidence that may interfere with the trial results, prevent the subjects from participating in the entire study, abnormal treatment or laboratory test values, or other circumstances that the researchers consider
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT;Maximum tolerated dose (MTD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the overall survival period of the subjects;The objective response rate of the subjects was evaluated according to RECIST V1.1;The local control rate of the subjects was evaluated according to RECIST V1.1;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactYue Jinbo
Affiliated Cancer Hospital of Shandong First Medical University
Outcome results
None listed