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NCT Number: NCT06443307

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Solid Tumor

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Jian Li, MD

SUB_INVESTIGATOR

Lin Shen, MD

CONTACT

[email protected]

(86)10-88196561

Lin Shen, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • 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.
  • 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.

Treatment and study plan

Irinotecan Liposome

Drug

The experimental group will collect data from patients treated with Nal-IRI as the chemotherapy regimen. It is recommended to use according to the label, clinical practice shall prevail.

Primary outcomes

  1. Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)

    Time frame: Assessed except to 10 months.

    To investigate the safety with Nal-IRI and IRI.

  2. Objective response rate (Cohort 2 and 4)

    Time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.

    To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.

  3. R0 resection rate (Cohort 3)

    Time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.

    To assess surgical conversion rates in patients who could be surgically resected.

Secondary outcomes

  1. Objective response rate (Cohort 1)

    Time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.

    To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.

  2. Disease control rate (Cohort 1,2,4)

    Time frame: From initial medication to the date of first documented progression or end of medication.Assessed up to 6 months.

    To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete , partial or stable response (SD) assessed by RECIST v1.1.

  3. Progression free survival (Cohort 1,2,4)

    Time frame: 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.

    To investigate antitumor efficacy of study. From initial medication to the date of first documented progression or end of medication, whichever came first.

  4. Overall survival (Cohort 1,2,4)

    Time frame: From initial medication to the date of death from any cause. Assessed up to 42 months.

    To investigate antitumor efficacy of Nal-IRI. From initial medication to the date of death from any cause.

  5. Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 (Cohort 1,2,3,4)

    Time frame: Assessed except to 24 months.

    To assess the incidence and severity of adverse events in combination regimens.

  6. Pathological complete response rate (Cohort 3)

    Time frame: After treatment and surgery, assessed up to 6 months.

    To investigate the effect of Nal-IRI.

  7. Event-free survival (Cohort 3)

    Time frame: The time from enrollment to any event, including death, disease progression, or switch to a treatment, occurred first. Assessed up to 12 months.

    To investigate the effect of Nal-IRI.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Shen

CONTACT

[email protected]

01088196561

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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