Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding (NCT04680195) | Clinical Trial Compass
UnknownPhase 2
Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
62 participantsStarted 2020-12-14
Plain-language summary
Chronic radiation proctitis (CRP) is the main secondary toxic injury after pelvic radiotherapy. Hematochezia is the most common symptom for more than 80% of CRP patients.
Non-surgical treatment is the first choice to the treatment of CRP to avoid the occurrence of serious complications. Conventional oral medication for the treatment of bleeding CRP is very few and has little effect. At present, no oral medication has been found to significantly alleviate and control refractory bleeding of CRP. Therefore, it is an urgent problem to screen out a drug that is more effective, safe and highly compliant for the treatment of hemorrhagic CRP.
Thalidomide has anti-inflammatory, immune regulation, anti-angiogenesis and other effects. For the patients of CRP with intractable bleeding, a prospective, open clinical trial will be carried out to observe the safety and effectiveness of thalidomide in treating hemorrhagic CRP.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients aged 18-75 years;
✓. Patients with ECOG physical condition score of 0-2;
✓. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
✓. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
✓. Patients with no primary tumor recurrence or metastasis;
✓. 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)
✓. Subjects and their family members can understand the research plan, and are willing to participate, and sign an informed consent form.
Exclusion criteria
✕. Patients with active bleeding requiring emergency treatment;
✕. Patients with severe complications of CRP, such as Rectal ulcer (VRS\>Grade 3) or fistula, perforation, stenosis, necrosis, perianal intractable pain and so on
What they're measuring
1
Remission rate of rectal bleeding one month after thalidomide treatment
Timeframe: the first month after thalidomide treatment
Trial details
NCT IDNCT04680195
SponsorSixth Affiliated Hospital, Sun Yat-sen University