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

NCT06443307 | Recruiting

• 1 other identifier: CSPC-DEY-CRC-K02
• Study Type: observational
• Target: 933
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Solid Tumor

Outcome Measures

Primary Outcomes (3)

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

  To investigate the safety with Nal-IRI and IRI.

  Assessed except to 10 months.

• Objective response rate (Cohort 2 and 4)

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

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

• R0 resection rate (Cohort 3)

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

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

Secondary Outcomes (7)

• Objective response rate (Cohort 1)

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

• Disease control rate (Cohort 1,2,4)

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

• Progression free survival (Cohort 1,2,4)

  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.

• Overall survival (Cohort 1,2,4)

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

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

  Assessed except to 24 months.

Study Arms (4)

Second-line treatment for colorectal cancer

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.

Drug: Irinotecan Liposome

Posterior line treatment of colorectal cancer

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.

Drug: Irinotecan Liposome

Neoadjuvant therapy for colorectal cancer

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

Drug: Irinotecan Liposome

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

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.

Drug: Irinotecan Liposome

Interventions

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.

Neoadjuvant therapy for colorectal cancer; Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment; Posterior line treatment of colorectal cancer; Second-line treatment for colorectal cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Lin Shen

CONTACT

01088196561; doctorshenlin@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 5, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

CN (1)