A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 933
- 试验地点
- 1
- 主要终点
- Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)
研究概览
简要总结
This study is a prospective, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease.
- •Known to be pMMR/MSS or MMR/MS status unknown.
- •Prior first-line systemic oxaliplatin - and fluorouracils-based therapy for metastatic disease progressed.
- •Patients had not received IRI or Nal-IRI during the treatment phase of metastatic disease.
- •Patients were scheduled to receive Nal-IRI plus fluorouracils or IRI plus fluorouracils chemotherapy regimens as second-line systemic therapy.
- •Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease;
- •Known to be pMMR/MSS or MMR/MS status unknown.
- •Patients had received ≤ 3 lines of previous treatment for metastatic disease.
- •Progression of metastatic disease after treatment with an IRI-containing regimen (no limit on the number of IRI treatment lines).
- •The patient had not previously received Nal-IRI and was scheduled to receive a systemic Nal-IRI containing chemotherapy regimen as palliative treatment.
- •Have at least one measurable lesion according to RECIST v1.
- •High-risk (CRS score 3-5) synchronous liver metastatic colorectal adenocarcinoma with ≤5 liver metastases, confirmed by histopathology or cytopathology, and planned resection.
- •Known to be pMMR/MSS or MMR/MS status unknown.
- •The patient was scheduled to receive Nal-IRI+ oxaliplatin + fluorouracils chemotherapy regimen as neoadjuvant therapy.
- •Non pancreatic cancer and non colorectal cancer patients confirmed by histopathology and/or cytology.
- •Have received at least one systemic treatment for unresectable diseases;
- •Plan to receive a systemic treatment regimen containing Nal IRI;
- •At least one measurable lesion (according to RECIST v1.1);
排除标准
- •Cohort 1-4:
- •Treatment with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab) was planned during chemotherapy.
- •Allergy to irinotecan or liposomal irinotecan and its excipients is known.
- •Female patients known to be pregnant or lactating.
- •Other patients who were deemed by the investigator to be ineligible for enrollment.
研究组 & 干预措施
Second-line treatment for colorectal cancer
Cohort 1 is a concurrent control design, including patients treated with irinotecan liposome (Nal-IRI) or irinotecan (IRI) plus fluorouracils as second-line treatment for metastatic colorectal cancer.
干预措施: Irinotecan Liposome (Drug)
Posterior line treatment of colorectal cancer
Cohort 2 is a Simon two-stage design, is planned to include patients who are treated with a NAL-IRI based combination regimen and have used IRI as a late-line treatment for metastatic colorectal cancer.
干预措施: Irinotecan Liposome (Drug)
Neoadjuvant therapy for colorectal cancer
Cohort 3 is a single-arm design and planned to enroll patients who received Nal-IRI+ oxaliplatin + fluorouracils as neoadjuvant chemotherapy for colorectal cancer.
干预措施: Irinotecan Liposome (Drug)
Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment
Cohort 4 is a single-arm design and is planned to enroll patients who are treated with the NAL-IRI containing regimen as second-line or beyond treatment for nonpancreatic, noncolorectal cancers.
干预措施: Irinotecan Liposome (Drug)
结局指标
主要结局
Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)
时间窗: Assessed except to 10 months.
To investigate the safety with Nal-IRI and IRI.
Objective response rate (Cohort 2 and 4)
时间窗: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.
R0 resection rate (Cohort 3)
时间窗: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
To assess surgical conversion rates in patients who could be surgically resected.
次要结局
- Objective response rate (Cohort 1)(From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.)
- Disease control rate (Cohort 1,2,4)(From initial medication to the date of first documented progression or end of medication.Assessed up to 6 months.)
- Progression free survival (Cohort 1,2,4)(From initial medication to the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.)
- Event-free survival (Cohort 3)(The time from enrollment to any event, including death, disease progression, or switch to a treatment, occurred first. Assessed up to 12 months.)
- Overall survival (Cohort 1,2,4)(From initial medication to the date of death from any cause. Assessed up to 42 months.)
- Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 (Cohort 1,2,3,4)(Assessed except to 24 months.)
- Pathological complete response rate (Cohort 3)(After treatment and surgery, assessed up to 6 months.)