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

Peking University

Status: Enrolling

Conditions: Solid Tumor; Colorectal Cancer

Treatments: Drug: Irinotecan Liposome

Study type: Observational

Funder types: Other

Identifiers

NCT06443307

CSPC-DEY-CRC-K02

Details and patient eligibility

About

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.

Enrollment: 933 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

933 participants in 4 patient groups

Second-line treatment for colorectal cancer

Description:

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.

Treatment:

Drug: Irinotecan Liposome

Posterior line treatment of colorectal cancer

Description:

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.

Treatment:

Drug: Irinotecan Liposome

Neoadjuvant therapy for colorectal cancer

Description:

Cohort 3 is a single-arm design and planned to enroll patients who received Nal-IRI+ oxaliplatin + fluorouracils as neoadjuvant chemotherapy for colorectal cancer.

Treatment:

Drug: Irinotecan Liposome

Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment

Description:

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.

Treatment:

Drug: Irinotecan Liposome