A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pathology complete remission rate
研究概览
简要总结
Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age:18-75 years
- •Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
- •The lower edge of the tumors located below 12 cm from the anal verge
- •Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
- •No prior chemotherapy was used
- •No history of regional radiation treatment inthe pelvic cavity
- •Adequate hematologic function: Hb ≥ 100 g/L , WBC≥3.5×109, ANC ≥ 1.5×109 /L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.5×ULN, TB≤2.5 × ULN Adequate hepatic function: ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 2.5×ULN
- •Patients without peripheral neuropathy
排除标准
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- •Rectal cancer patients with concurrent colon cancer
- •Pregnant or lactating women
- •Fertile female patients without using any contraceptives
- •Allergic to cisplatin and fluorouracil
- •Patients with previous peripheral neuropathy
- •Serious complications: myocardial infarction, heart failure (NYHA Classification>II grade),psychiatric history and severe diabetes
- •Treatment with other anti-cancer therapy(including Chinese herbal medicine)
- •Organ transplant patients
研究组 & 干预措施
Nimotuzumab plus chemoradiotherapy
干预措施: Preoperative irradiation (Radiation)
Nimotuzumab plus chemoradiotherapy
干预措施: Nimotuzumab (Drug)
Nimotuzumab plus chemoradiotherapy
干预措施: Oxaliplatin (Drug)
Nimotuzumab plus chemoradiotherapy
干预措施: Capecitabine (Drug)
结局指标
主要结局
Pathology complete remission rate
时间窗: 1 year
Pathology complete remission rate is the primary outcome measure.
次要结局
- Incidence of Adverse Events(up to 1 month after the last cycle)
- local recurrence rate(5 years)
- overall survival(5 years)
- sphincter preservation rate(3 years)
- tumor regression rate(1 year)