The Role and Intervention of TGF-β in Abdominal Radiation Injury

Study Overview
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Brief Summary
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This project aims to investigate the relationship between radiation-induced the relationship between elevated peripheral blood TGFβ and complications of radiotherapy,and to analysis of changes in peripheral blood TGFβ levels after abdominal radiotherapy and its relationship with radiotherapy complications.Simultaneously,Patients who underwent abdominal radiotherapy were given captopril (sustained release) to block TGFβ,Whether it can reduce peripheral blood TGFβ levels and reduce radiotherapy complications,to explore the protective effect of blocking TGFβ secretion on normal tissues after radiotherapy.

Official Title
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The Role of TGF-β in Abdominal Radiation Injury and Taking Medicine to Block TGF-β for Protecting Normal Organization

Conditions
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Radiotherapy Side Effect, Taking Captopril

Intervention / Treatment
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* Drug: Captopril 12.5 Mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form for this study has been signed Age 18-70 years old, gender is not limited，Pathological diagnosis of patients with advanced malignant tumors，Radiotherapy indications； BED (α/β=10)≥50；ECOG score 0-2；Blood routine：WBC≥3.5×109/L,GRAN≥2.0×109/L,Hb≥90g/L，PLT≥100×109/L; Liver function: ALT or AST ≤ 2.5 times the normal high value (ULN)；Bilirubin ≤ 1.5 × ULN, serum APK ≤ 2.5 × ULN; Renal function：Serum creatinine ≤1.5×ULN, and creatinine clearance ≥60ml/min No organ transplant history Women of childbearing age must undergo a urine pregnancy test within 7 days prior to initiation of treatment and the results are negative and not in lactation Male and female patients of childbearing age agreed to adopt a reliable method of contraception before entering the trial and during the study until 30 days after stopping the drug. Exclusion Criteria: Patients undergoing chemotherapy or targeted therapy at the same time Long-term use of ACEI or ARB drugs for hypertension This radiotherapy site has been treated with radiotherapy；Combined with severe heart disease or major organ failure Have a history of drug abuse or alcohol addiction Combined active infection Combined with severe malnutrition or severe anemia Human immunodeficiency virus (HIV) infection During pregnancy or lactation Those who are unable to tolerate or may be allergic to the drugs used in this study；Persons without civil capacity or limited capacity for civil conduct； Researchers believe that it is not suitable for inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral blood TGF-β content before and after radiotherapy<br> | Drug: Captopril 12.5 Mg<br>* Taking captopril 12.5mg b.i.d for two months before radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the effect of abdominal radiation therapy on peripheral blood TGFβ levels | The levels of TGF-β in peripheral blood of patients before and after radiotherapy were compared. | 12 weeks | 
| Blocking TGFβ for protective effect on normal tissues | Give two groups of patients captopril (sustained release) 12.5mg b.i.d. for two months,comparing their levels of TGF-β in peripheral blood | 12 weeks |