Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer：an Open-label, Single-arm, Multicenter Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The ratio of tumor downstaging to stage 0 and stage I
研究概览
简要总结
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with resectable liver metastasis of colorectal cancer
详细描述
For the patients Neoadjuvant FOLFOX chemotherapy is recommended for the resectable liver metastasis colorectal cancer. Neoadjuvant chemotherapy could suppress tumor, reduce metastasis, inhibit recurrence and improve long-term prognosis. Moreover, neoadjuvant chemotherapy could provide evidence about tumor response to drugs for the adjuvant chemotherapy. Furthermore, according to the biological behavior of tumors observed by neoadjuvant chemotherapy, unnecessarily excessive surgery could be avoided. However, some studies suggested that drug efficiency was consistent with resection rate. And FOLFOXIRI has been observed efficacy in the treatment of metastatic colorectal cancer with manageable toxicities. Therefore, we evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy in the patients with resectable liver metastasis of colorectal cancer to achieve higher resection rate and longer survival.
In this prospective study, 30 patients with resectable colorectal liver metastases were treated with neoadjuvant FOLFOXIRI chemotherapy. After 4 cycles of neoadjuvant chemotherapy, the liver metastases will be removed. If there are primary bowel lesions, they will be resected together. Safety profile was recorded based on NCI Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0). Objective response was evaluated by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Before treatment and after 4 cycles of neoadjuvant chemotherapy, we will evaluate tumor metabolic response via FDG-PET and monitor the dynamic changes of peripheral blood ctDNA.
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
- 未提供
排除标准
- •Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- •In addition to liver metastases, there are other parts of metastasis
- •Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; Active ischemic heart disease; Myocardial infarction within the past 6 months; Symptomatic arrhythmia Uncontrolled hypertension. Unexplained syncope occurred within 3 months
- •Gastric ulcers or duodenal ulcers for the treatment of resistance;
- •3 or 4 grade gastrointestinal bleeding / bleeding;
- •Gastrointestinal perforation / fistula;
- •Abdominal abscess;
- •Infectious or inflammatory bowel disease
- •HIV infection and/or active hepatitis B virus infection
- •Pregnant or lactating women. Fertile patients must use effective contraception
- •Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study
- •Other intervention clinical trials were combined at the same time.
- •Nerve or mental abnormality affecting cognitive ability
- •Other malignancy except effectively treated squamous cell or basal cell skin cancer,
- •Other situations that the researchers think should be excluded.
研究组 & 干预措施
FOLFOXIRI
Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection.
干预措施: FOLFOXIRI (Drug)
结局指标
主要结局
The ratio of tumor downstaging to stage 0 and stage I
时间窗: 2 years
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
次要结局
- Tumor regression grade (TRG)(2 years)
- Overall survival time(3 years)
- Disease free survival(3 years)
- ctDNA assessment and relation to clinical outcome(3 years)
- SUVmax assessment and relation to clinical outcome(At the beginning of Cycle 1 and the end of Cycle 4 (each cycle is 14 days))
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3 years)
- Quality of life (QLQ C30)(Every 2 weeks after the first treatment until 3 years)
研究者
Jingdong Zhang
Director
China Medical University, China