Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan

A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan

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.

Inclusion Criteria:

1. Cohort 1:

   • 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.

2. Cohort 2:

   • 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 v1.1.

3. Cohort 3:

   • 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.

4. Cohort 4:

   • 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);

Exclusion Criteria:

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.