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

Inclusion Criteria:

1. Cohort 1:

• Patients with histologically or cytopathologically confirmed colorectaladenocarcinoma 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 formetastatic disease progressed.

• Patients had not received IRI or Nal-IRI during the treatment phase ofmetastatic disease.

• Patients were scheduled to receive Nal-IRI plus fluorouracils or IRI plusfluorouracils chemotherapy regimens as second-line systemic therapy.

2. Cohort 2:

• Patients with histologically or cytopathologically confirmed colorectaladenocarcinoma 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-containingregimen (no limit on the number of IRI treatment lines).

• The patient had not previously received Nal-IRI and was scheduled to receive asystemic 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 colorectaladenocarcinoma with ≤5 liver metastases, confirmed by histopathology orcytopathology, and planned resection.

• Known to be pMMR/MSS or MMR/MS status unknown.

• The patient was scheduled to receive Nal-IRI+ oxaliplatin + fluorouracilschemotherapy regimen as neoadjuvant therapy.

4. Cohort 4:

• Non pancreatic cancer and non colorectal cancer patients confirmed byhistopathology 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) wasplanned 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.