2024-519050-37-00招募中2 期
ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY - LARC_ DEEP_CANCERS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Evaluation of the safety and feasibility
研究概览
简要总结
Evaluation of the safety and feasibility of the procedure and of the increase of the complete response rate with the aim of organ sparing. Evaluated by histopathological analysis based on TRG performed on specimen exported from local excision.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥18 years
- •Histological confirmation of rectal adenocarcinoma
- •Patients undergoing neoadjuvant treatment for locally advanced tumor of the rectum with confirmed major clinical response after neoadjuvant treatment
- •Rectal tumor up to 12 cm from the external anal margin
- •Patients must be willing to comply with the study protocol and give their informed written consent.
- •Patients with an ECOG status performance <3
排除标准
- •Age less than 18 years
- •Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;
- •Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)
- •Pregnancy or lactation
- •Patients with neoplasia more than 12 cm from the anal margin
- •Patients with stable disease or disease progression after neoadjuvant treatment
- •Patients, who for medical reasons, cannot be given bleomycin
- •Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);
- •Acute lung infection;
- •Symptoms of poor lung function;
- •Non correctable severe coagulation disorders;
- •Previous allergic reactions to bleomycin;
结局指标
主要结局
Evaluation of the safety and feasibility
Evaluation of the safety and feasibility
Increase in the rate of complete histopathological response in the treatment arm compared to the control arm.
Increase in the rate of complete histopathological response in the treatment arm compared to the control arm.
次要结局
未报告次要终点
研究者
Paolo Delrio
Scientific
IRCCS Istituto Nazionale Tumori Fondazione Pascale
研究点 (7)
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