NCT04224415已完成2 期
Re-challenge of Anti-EGFR Agents for Chinese Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer
Yuhong Li1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The aim of the trial is to study the efficacy and safety of Cetuximab re-challenge for Chinese Patients with RAS/BRAF wild-type Metastatic Colorectal Cancer.
详细描述
After first-line treatment of FOLFOX/FOLFIRI/FOLFOXIRI plus Cetuximab failure and defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA, the patients will be treated with Cetuximab and Irinotecan as a second-line or third-line treatment.
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
- 是
入选标准
- •Age ≥ 18 and ≤
- •Diagnosed as colorectal adenocarcinoma by histology.
- •Initially confirmed as RAS/BRAF wild type by tissue molecular detection.
- •Treated with first-line therapy of FOLFOX/FOLFIRI/FOLFOXIRI+Cetuximab effectively and the PFS is not less than 6 months.
- •Tumor progression during Cetuximab treatment or after treatment within 3 months.
- •Tumor progression again after second-line treatment.
- •The interval time of re-challenge is more than 4 months after the last time treated with Cetuximab.
- •Lesions can be measured by the standard of RECIST v1.
- •Defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA,
- •No hematologic dysfunction(Platelets >90×10^9/L; WBC >3×10^9/L; Neutrophil >1.5×10^9/L；Hemoglobin >10 g/100ml).
- •Serum bilirubin ≤ 1.5 × ULN; aminotransferase ≤ 5 × ULN.
- •No ascites; no coagulation dysfunction; albumin ≥ 30g/L.
- •Hepatic function was classified as class A by Child-Pugh classification.
- •Serum creatinine < 1 × ULN, or creatinine clearance rate(CCR) > 50ml/ min(calculated by Cockcroft-Gault formula).
- •ECOG scored as 0-
- •Life expectancy > 3 months.
- •Informed consent.
- •Willing and able to receive follow-up until death or trial is finished or trial is terminated.
排除标准
- •RAS/BRAF mutation.
- •Severe arterial embolism or ascites.
- •Presence of hemorrhagic tendency or coagulation dysfunction.
- •Presence of hypertensive crisis or hypertensive encephalopathy.
- •Severe uncontrolled systemic complications, such as infection or diabetes.
- •Severe clinical CVD(cardiovascular disease), such as cerebrovascular accident(within 6 months before recruitment), myocardial infarction(within 6 months before recruitment), uncontrolled hypertension; unstable angina pectoris; congestive heart-failure(NYHA 2-4 grade); arrhythmia that needs medication treatment.
- •Previous diagnosed or physical examination showed presence of central nervous system(CNS) disease(i.e. primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastases or stroke).
- •Previous history of other malignancy within 5 years(except basal cell carcinoma after radical resection and/or cervical carcinoma in situ).
- •Received any medication under research within 28 days before the trial.
- •Any residual toxicity of previous chemotherapy(except hair loss), i.e. peripheral neuropathy ≥ NCI CTC v3.0 Grade 2, will be excluded from oxaliplatin-based chemotherapy regimen research pair.
- •Allergic to any medication involved in the trial.
- •Pregnant and lactating women.
- •Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility.
- •Unable or unwilling to comply with the research plan.
- •The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications
研究组 & 干预措施
C225+CPT-11
Other
Patients will receive Systemic C225+CPT-11 every 14 days:
C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1
干预措施: C225+CPT-11 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to 2-4 months
defined as complete remission rates and partial remission rates after treatment.
次要结局
- Overall Survival(OS)(Up to 12 months)
- Progress-free Survival(PFS)(Up to 2-4 months)
- Adverse events(AE) and severe adverse events(SAE)(Up to 6 months)
研究者
Yuhong Li
Clinical Professor
Sun Yat-sen University
研究点 (1)
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