NCT05079438招募中3 期
A Multicenter Randomized Controlled Stage III Clinical Study of Dendrobium Huoshanense Suppository in Locally Advanced Rectal Cancer Patients Treated by Neoadjuvant Chemoradiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- ≥Grade 2 proctitis
研究概览
简要总结
To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological confirmed rectum adenocarcinoma
- •clinical stage T3-4 and/or N+
- •the distance from anal verge less than 10 cm
- •without distance metastases
- •performance status score: 0~1
- •without previous anti-cancer therapy
- •able to follow the protocol during the study period
- •sign the inform consen
排除标准
- •Pregnant or breastfeeding women
- •Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
- •If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- •Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- •Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- •Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
- •Anyone who is allergic to any research medication
- •DPD deficiency
研究组 & 干预措施
CRT with Dendrobium huoshanense Suppository
Experimental
Dendrobium huoshanense Suppository: 1.7g rectal administration per day for 5 weeks
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1*28 and *6 ：7/7+GG or 6/6+AA or 6/7+GA）.
干预措施: Dendrobium Huoshanense Suppository (Drug)
结局指标
主要结局
≥Grade 2 proctitis
时间窗: During chemoradiotherapy
次要结局
未报告次要终点
研究者
zhuji
Professor
Zhejiang Cancer Hospital
研究点 (1)
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