Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT04680195
Eligibility Criteria:
Inclusion criteria
1. Patients aged 18-75 years;
2. Patients with ECOG physical condition score of 0-2;
3. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
4. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
5. Patients with no primary tumor recurrence or metastasis;
6. Patients with refractory hemorrhagic CRP who have failed to conventional treatment (SOMA score for hematochezia≥2, hemoglobin level ≤90g/L, or a history of blood transfusion due to CRP)
7. Subjects and their family members can understand the research plan, and are willing to participate, and sign an informed consent form.
Exclusion Criteria:
1. Patients with active bleeding requiring emergency treatment;
2. Patients with severe complications of CRP, such as Rectal ulcer (VRS\>Grade 3) or fistula, perforation, stenosis, necrosis, perianal intractable pain and so on
3. Patients with a history of rectal resection;
4. Other bleeding diseases, such as grade III or IV hemorrhoids, coagulation dysfunction, etc.;
5. Patients with other diseases requiring long-term use of anticoagulant drugs;
6. Combined intestinal obstruction, requiring surgery;
7. The absolute value of neutrophils of patients is lower than 750/mm3;
8. Patients who are allergic to thalidomide;
9. Pregnant or lactating women;
10. Patients with severe mental illness;
11. Patients who cannot take medication or follow up as planned;
12. During the trial and within 3 months after the trial, the subjects and their partners are not willing to contraception;
13. Participants in other clinical investigators 3 months before the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04680195
Study Brief:
Protocol Section:
NCT04680195