NCT04620473撤回2 期
Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal cancer-a Prospective, Open, Single Center and Randomized Controlled Phase Ⅱ Clinical Trial
Shanghai Minimally Invasive Surgery Center0 个研究点开始时间: 2023年11月1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
- 撤回
- 发起方
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
Prospectively Investigate the effectiveness and safety of anlotinib hydrochloride combined with Capeox in neoadjuvant treatment of patients with locally advanced rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
- •Male or female patients between the ages of 18-75;
- •Patients diagnosed as rectal adenocarcinoma by histology or cytology;
- •Stage: Locally advanced stage (T3-4N0M0 or T1-4N+M0);
- •Evaluation of middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin by MRI;
- •Have not received other anti-angiogenic drugs or chemotherapy drugs in the past;
- •ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
- •Has sufficient organ and bone marrow function
排除标准
- •Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
- •A distant transfer occurs;
- •Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
- •Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
- •Patients with any severe and/or uncontrollable disease；
- •Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
- •Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- •Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping;
- •Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
- •Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- •People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- •Participated in other anti-tumor drug clinical trials within four weeks;
- •According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
- •Female patients who are pregnant or breastfeeding;
- •Known hypersensitivity to any study drug.
研究组 & 干预措施
Anlotinib+Capeox
Experimental
neoadjuvant treatment with Anlotinib hydrochloride combined with Capeox
干预措施: Anlotinib+Capeox (Drug)
Capeox
Active Comparator
neoadjuvant treatment with Capeox
干预措施: Capeox (Drug)
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: an average of three months
Refers to the proportion of subjects whose tumors have shrunk to a certain amount and maintained for a certain period of time in the FAS concentration, including CR and PR cases
次要结局
- Overall survive(3 years after surgery)
- Pathological complete response rate(one month after surgery)
- R0 resection rate(one month after surgery)
- Disease-free survival rate(3 years after surgery)
- Local disease recurrence time(3 years after surgery)
- Postoperative complications(one month after surgery)
研究者
Cai Zhenghao
Attending surgeon of gastrointestinal surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai Minimally Invasive Surgery Center
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