A Multi-center、Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression free survival, PFS
研究概览
简要总结
The goal of this prospective observational study is to learn about the treatment decisions in advanced colorectal cancer treated with oxaliplatin and irinotecan. The main questions:1. learn about the efficacy and safety of immunotherapy or targeted drugs or other chemotherapy for patients treated with oxaliplatin and irinotecan（non-retreatment/rechallenge group，NR group）. 2. learn about the efficacy and safety of oxaliplatin or irinotecan for patients treated with oxaliplatin and irinotecan (retreatment/rechallenge group, RT/RC group). 3. compare the efficacy and safety of various treatment regimens for patients treated with oxaliplatin and irinotecan. This study will only collect the clinical data of patients, without any intervention, in the treatment services. All participants will be provided written informed consent as per the Declaration of Helsinki principles.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phologically confirmed colorectal adenocarcinoma
- •Treated by oxaliplatin and irinotecan and discontinued due to progression or intolerable drug toxicity
- •Predicted survival more than 3 months
- •Estimated by investigators that the main organ function is enough good to tolerate the next treatment plan.
- •Sign informed consent.
- •Agree to receive survival follow-up
排除标准
- •Previously exposed to regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, or targeted drugs or immunotherapy for HER2 amplification, BRAF V600E mutation, and NTRK gene fusion.
- •Previously rechallenged or retreated by oxaliplatin or irinotecan after progression from chemotherapy regimens including oxaliplatin and irinotecan.
- •Participate in another interventional clinical study at the same time, unless in the follow-up stage of intervention study.
- •Proposed to use a treatment regimen containing regorafenib, furquintinib, and trifluridine, but has any problems obstacling oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction et al.
- •Disagree to take contraceptive measures during the study treatment period or within 6 months after the end of the study treatment period.
- •Has other primary malignant tumor history, unless non-melanoma skin cancer or lentigo maligna or carcinoma in situ with sufficient treatment and no disease recurrence.
- •Has the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Has concomitant diseases that seriously endanger patient safety or affect patient completion of the study.
- •Has other problems that is not suitable for clinical research.
结局指标
主要结局
Progression free survival, PFS
时间窗: Up to 12 months
PFS was calculated as the time from the date of treatment initiation to the date of disease progression or the last follow-up
Overall Survival, OS
时间窗: Up to 24 months
OS was calculated as the time from the date of treatment initiation to the date of any cause of death, or the last follow-up.
次要结局
- Objective response rate ，ORR(Up to 12 months)
- Disease Control Rate，DCR(Up to 12 months)
- Quality of life score(Up to 24 months)
- Comprehensive score of economic burden(Up to 24 months)
- Adverse events, AEs(Up to 24 months)
研究者
Dong sheng Zhang
Professor
Sun Yat-sen University