radiation-induced fibrosis
Conditions
Interventions
Experimental group:pirfenidone 400mg/tid
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years (including 18 and 75 years old); 2. Clinical diagnosis of stage II-III rectal cancer; 3. Receive long-term radiotherapy (45Gy/25f/5w); 4. General status ECOG (Eastern Cooperative Oncology Group) determines the clinical status is 0-1; 5. The expected survival period is more than 6 months; 6. Liver and kidney functions: such as plasma total bilirubin and creatinine <= 1.5 times the upper limit of normal; AST, ALT, LDH <= 2 times the upper limit of normal; 7. The subject voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Past history of pelvic radiotherapy; 2. Patients with a history of pelvic surgery; 3. History of other tumors or rectal malignant tumors that occurred on the basis of inflammatory bowel disease; 4. Emergency surgery is required due to intestinal obstruction, perforation, bleeding, etc.,and with unresectable concurrent intestinal diseases; 5. Long-term use of metformin hypoglycemic drugs; 6. Creatinine clearance rate <30ml/min and those with severe kidney disease or requiring dialysis; 7. Combined with other serious diseases: such as myocardial infarction and uncontrollable diabetes within 6 months, those who are considered unsuitable to participate in the trial; 8. Patients who cannot undergo MRI examination due to contraindications or relative contraindications in MRI examination; 9. Accompanied by active peptic ulcer; 10. Pregnant women and patients with mental illness; 11. Participated in other drug clinical trials within 3 months; 12. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of fibrosis at the proximal end of the rectum (10cm from the tumor); | — |
Countries
China
Contacts
Public ContactChi Pan, Chen Zhifen, Liu Zhun
Fujian Medical University Union Hospital
Outcome results
None listed