Evaluating the effectiveness and safety of Liposome Irinotecan for colorectal cancer

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

This study is testing if Liposome Irinotecan can help people with advanced colorectal cancer and other solid tumors feel better and stay safe while receiving treatment.

Quick facts

• Study type: Observational
• Enrollment: 933 (estimated)
• Sex: All
• Sponsor: Peking University (Academic / other)
• Drugs / interventions: pembrolizumab, nivolumab, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06443307 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, real-world study designed to evaluate the efficacy and safety of Liposome Irinotecan in patients with colorectal cancer and other solid tumors. The study consists of four cohorts, focusing on patients with unresectable metastatic colorectal cancer who have received various lines of prior treatment. Treatment procedures and assessments will follow routine clinical practices, allowing for a comprehensive observation of outcomes in a real-world setting. The study aims to gather data on the effectiveness of Liposome Irinotecan in these patient populations.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable metastatic colorectal adenocarcinoma who have progressed after first-line therapy and are scheduled to receive Liposome Irinotecan as part of their treatment.

Not a fit: Patients with pancreatic cancer or those who have already received Liposome Irinotecan or Nal-IRI during their treatment phase will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Liposome Irinotecan, potentially improving treatment options for patients with advanced colorectal cancer.

How similar studies have performed: While this study utilizes a real-world approach, similar studies evaluating Liposome Irinotecan have shown promise, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lin Shen

Conditions Colorectal Cancer; Solid Tumor