NCT07065175尚未招募2 期
KANGFUPEN (Liquid Dressing) for the Treatment of Chronic Radiation-Induced Rectal Injury: A Prospective, Single-Arm, Multicenter Study
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in LENT-SOMA rectal radiation injury scores from baseline to 3 months post-treatment
研究概览
简要总结
This clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are:
- Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment?
- Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)?
- What adverse events occur with Kangfupen therapy? Kangfupen liquid dressing (50 mL/once daily) will be administered as retention enema for 3-6 months, adjusted based on lesion location.
Researchers will evaluate the following outcomes to assess Kangfupen's efficacy and safety in treating chronic radiation proctitis:
- Change in LENT-SOMA rectal injury score (baseline vs. 3 months).
- Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores.
- Symptom improvement rate and time to complete remission.
Participant will:
- Undergo baseline and 3-month endoscopic evaluations.
- Complete symptom diaries and quality-of-life questionnaires.
- Attend regular clinic visits for safety monitoring.
详细描述
Baseline Assessments
All enrolled patients must complete the following evaluations:
- Medical history including primary tumor type, histopathology, staging and radiotherapy details (timing, technique, and total dose)
- Physical examination
- ECOG performance status
- Laboratory tests including complete blood count, stool occult blood, liver/kidney function and tumor markers
- Pelvic scans to exclude tumor recurrence/progression
- Full colonoscopy with photographic documentation. Images every 5cm from anus to splenic flexure, and at sites of severe mucosal reaction additionally
- Grading based on LENT-SOMA, RTOG, and CTCAE v5.0 criteria
Treatment protocol Kangfupen (liquid dressing) retention enema
- Dosage: 50 mL once daily for 3-6 months
- Administration depth: Determined by colonoscopy findings Enema preparation & administration 1. Reconstitution:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully voluntary with decision-making capacity
- •18-80 years old
- •Completed pelvic radiotherapy for malignancy ≥3 months prior
- •Evidence of chronic radiation-induced rectal injury (RTOG Grade ≥2)
- •Evidence of radiation-induced rectal injury on colonoscopy (within 3 months, Vienna endoscopic score ≥1)
- •No prior surgery
- •ECOG score 0-2
- •Estimated survival ≥1 year
排除标准
- •Primary rectal tumours or pelvic malignancies with rectal involvement
- •Uncontrolled, recurrent, or metastatic tumours
- •Concurrent anticancer therapies including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine with anti-tumour properties
- •Patients with intestinal fistula, perforation, or obstruction
- •History of electrocautery treatment within 1 month
- •Recent medication use (within 2 weeks): traditional Chinese medicine enemas, mesalazine (oral or rectal) and other anti-inflammatory bowel medications
- •History of superoxide dismutase allergy
- •Pre-existing chronic colitis, ulcerative colitis, or nonspecific proctitis
- •Connective tissue diseases requiring long-term corticosteroid therapy
- •Pregnant or lactating women
- •Active infection or fever
- •Other severe comorbidities potentially affecting trial compliance: unstable cardiac disease requiring treatment, renal disorders, chronic hepatitis, poorly controlled diabetes and psychiatric illnesses
研究组 & 干预措施
All enrolled patients
Experimental
All enrolled patients receive the same investigational intervention (Kangfupen liquid dressing enema). Scientific comparison is achieved through Pre- vs. post-treatment (3/6/12mo) parameter changes (e.g., ΔLENT-SOMA).
干预措施: Kangfupen (liquid dressing) retention enema administration (Drug)
结局指标
主要结局
Change in LENT-SOMA rectal radiation injury scores from baseline to 3 months post-treatment
时间窗: From enrolment to 3 months post-treatment
Treatment response is defined as: 1. Effective: Decrease in LENT-SOMA score compared to baseline 2. Ineffective: No change or increase in LENT-SOMA score versus baseline
次要结局
- Change in Vienna endoscopic scores from baseline to post-treatment(From enrolment to 3 months post-treatment)
- Changes in RTOG and CTCAE grading from baseline to post-treatment assessments(From enrolment to 3 months post-treatment)
- Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Function and Bleeding Scores from baseline to post-treatment(From enrolment to 3 months post-treatment)
- Post-treatment symptom improvement rate(From enrolment to 3 months post-treatment)
研究者
研究点 (1)
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