Clinical trial NCT03613506: The Role and Intervention of TGF-β in Abdominal Radiation Injury
Official title: The Role of TGF-β in Abdominal Radiation Injury and Taking Medicine to Block TGF-β for Protecting Normal Organization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radiotherapy Side Effect
Taking Captopril
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Informed consent form for this study has been signed
2. Age 18-70 years old, gender is not limited，Pathological diagnosis of patients with advanced malignant tumors，Radiotherapy indications；
3. 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;
4. Liver function: ALT or AST ≤ 2.5 times the normal high value (ULN)；Bilirubin ≤ 1.5 × ULN, serum APK ≤ 2.5 × ULN;
5. Renal function：Serum creatinine ≤1.5×ULN, and creatinine clearance ≥60ml/min
6. No organ transplant history
7. 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
8. 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:

1. Patients undergoing chemotherapy or targeted therapy at the same time
2. Long-term use of ACEI or ARB drugs for hypertension
3. This radiotherapy site has been treated with radiotherapy；Combined with severe heart disease or major organ failure
4. Have a history of drug abuse or alcohol addiction
5. Combined active infection
6. Combined with severe malnutrition or severe anemia
7. Human immunodeficiency virus (HIV) infection
8. During pregnancy or lactation
9. 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；
10. Researchers believe that it is not suitable for inclusion

Primary outcomes:
measure: Study the effect of abdominal radiation therapy on peripheral blood TGFβ levels
timeFrame: 12 weeks
measure: Blocking TGFβ for protective effect on normal tissues
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Jin Peng
state: Hubei
Study officials:
References: