NCT06617052尚未招募不适用
Efficacy and Safety of Preoperative (Chemo)Radiotherapy for Locally Recurrent Rectal Cancer: A Prospective, Single-arm Observational Study
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pathologic complete response
研究概览
简要总结
Through an observational study, the efficacy and safety of preoperative chemoradiotherapy followed by surgery in patients with recurrent rectal cancer were assessed. The primary population included patients with (potentially) resectable locally recurrent rectal cancer, excluding those with distant metastases. The study design was a prospective, open-label, single-arm observational study. The primary endpoint was the pCR (pathological complete response) rate, while secondary endpoints included R0 resection rate, local recurrence-free survival, overall survival, and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age between 18 and 75 years
- •ECOG performance status of 0-1
- •Histologically, cytologically, or MRI/contrast-enhanced CT confirmed pelvic recurrence. At least one measurable pelvic lesion according to RECIST 1.1
- •No distant metastases outside the pelvis
- •(Potentially) resectable lesion
- •No history of radiotherapy within the 6 months prior to enrollment
- •No prior chemotherapy; or received postoperative adjuvant therapy but not systemic chemotherapy for metastatic lesions
- •Investigator-assessed life expectancy of at least 24 weeks
- •Adequate organ function (bone marrow, liver, kidney, and coagulation function) demonstrated within 7 days prior to the first dose, without the use of blood products or hematopoietic growth factors
- •Not pregnant or breastfeeding. Effective contraception must be used during the study and for 6 months after the last dose
- •Fully informed and willing to provide written informed consent to participate in the trial
排除标准
- •Severe electrolyte abnormalities
- •Active coronary artery disease, severe/unstable angina, newly diagnosed angina, or myocardial infarction within 12 months prior to study participation Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein thrombosis within the past 6 months
- •New York Heart Association (NYHA) class II or higher congestive heart failure
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU/ml, or hepatitis C defined as HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C
- •Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea
- •Any active, known, or suspected autoimmune disease. Stable conditions not required systemic immunosuppressive therapy are allowed, such as type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin conditions (e.g., vitiligo, psoriasis, and alopecia) not requiring systemic treatment
- •Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, or acute pneumonia)
- •Known or suspected history of allergy to any study-related medications
- •Clinically detectable second primary malignancy or history of another malignancy within the past 5 years
- •Pregnant or breastfeeding women, or women with a positive pregnancy test before the first dose, or female participants and their partners unwilling to use strict contraception during the study
- •Any clinical or laboratory abnormalities or compliance issues that the investigator deems unsuitable for study participation
- •Severe psychiatric disorders
结局指标
主要结局
pathologic complete response
时间窗: up to 26 weeks
The resected tumor tissue and regional lymph nodes were pathologically assessed, revealing no residual tumor cells. The tumor lesions had completely disappeared, and no new lesions were detected.
次要结局
- R0 rates(up to 26 weeks)
- progression-free survival(5 years)
- overall survival(5 years)
研究者
研究点 (1)
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