Clinical trial NCT06443307: Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
Official title: A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Solid Tumor
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 933
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was a prospective, multicenter real-world study with four cohorts. Cohort 1 include patients as second-line treatment for metastatic colorectal cancer. Cohort 2 include patients as a late-line treatment for metastatic colorectal cancer. Cohort 3 include patients as neoadjuvant chemotherapy for colorectal cancer.

Cohort 4 include patients as second-line or beyond treatment for nonpancreatic, noncolorectal cancers. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)
timeFrame: Assessed except to 10 months.
measure: Objective response rate (Cohort 2 and 4)
timeFrame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
measure: R0 resection rate (Cohort 3)
timeFrame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
Secondary outcomes:
measure: Objective response rate (Cohort 1)
timeFrame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
measure: Disease control rate (Cohort 1,2,4)
timeFrame: From initial medication to the date of first documented progression or end of medication.Assessed up to 6 months.
measure: Progression free survival (Cohort 1,2,4)
timeFrame: From initial medication to the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
measure: Overall survival (Cohort 1,2,4)
timeFrame: From initial medication to the date of death from any cause. Assessed up to 42 months.
measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 (Cohort 1,2,3,4)
timeFrame: Assessed except to 24 months.
measure: Pathological complete response rate (Cohort 3)
timeFrame: After treatment and surgery, assessed up to 6 months.
measure: Event-free survival (Cohort 3)
timeFrame: The time from enrollment to any event, including death, disease progression, or switch to a treatment, occurred first. Assessed up to 12 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: