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Liposome Irinotecan for Colorectal Cancer

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

Recruiting Observational Study

Colorectal Cancer Solid Tumor

No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.

At a Glance

Sex: Any
Study type: Observational
Participants needed: 933 (estimated)
Sponsor: Peking University · Other

Who this trial is looking for

This trial is looking for patients with colorectal cancer or certain solid tumors who are receiving specific treatment plans. Participants will be treated with liposome irinotecan alongside other chemotherapy medications as part of their regular care.

Are You a Good Fit for This Trial?

You may be able to join if

I have been diagnosed with colorectal adenocarcinoma.
I have unresectable metastatic disease.
I have received previous treatment for my metastatic disease.
I am scheduled to receive a chemotherapy regimen.
I have at least one measurable lesion.

You may not be able to join if

I have planned treatment with an immune checkpoint inhibitor.
I am allergic to irinotecan or liposomal irinotecan.
I am pregnant or breastfeeding.
The investigator has deemed me ineligible.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility

About This Trial

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 o…

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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.

Contacts

Lin Shen

01088196561

doctorshenlin@sina.cn

CONTACT

Liposome Irinotecan for Colorectal Cancer

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