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

Launched by PEKING UNIVERSITY · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called liposome irinotecan for patients with colorectal cancer and other solid tumors. It is a real-world study, meaning it observes patients as they receive treatment in their regular healthcare settings rather than a controlled environment. There are four groups of participants: those receiving treatment as a second-line option after their first treatment has failed, those who have had multiple treatments but need a new option, those with specific liver cancer cases preparing for surgery, and finally, patients with other types of cancer who are not eligible for the first three groups.

To be eligible, participants generally need to have a confirmed diagnosis of colorectal cancer or another solid tumor and should have already received at least one prior treatment. Participants can expect to follow their regular treatment schedule with their doctors, who will monitor the effects of liposome irinotecan as part of their routine care. It’s important to note that individuals who are pregnant, breastfeeding, or have certain allergies to the treatment will not be eligible to join this study. If you or a loved one is considering participation, this trial may provide access to a new treatment option while contributing to important research on its benefits and safety.

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Eligibility criteria

• 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.