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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443307
• Other study ID #: CSPC-DEY-CRC-K02
• Status: Recruiting
• Start date: July 15, 2024
• Est. completion date: August 1, 2026

Study information

• Verified date: May 2024
• Source: Peking University
• Contact: Lin Shen
• Phone: 01088196561
• Email: doctorshenlin[@]sina.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 933
• Est. completion date: August 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Solid Tumor

Intervention

Drug:
• Irinotecan Liposome
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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Objective response rate (Cohort 1)	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.
Secondary	Disease control rate (Cohort 1,2,4)	To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete , partial or stable response (SD) assessed by RECIST v1.1.	From initial medication to the date of first documented progression or end of medication.Assessed up to 6 months.
Secondary	Progression free survival (Cohort 1,2,4)	To investigate antitumor efficacy of study. From initial medication to the date of first documented progression or end of medication, whichever came first.	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.
Secondary	Overall survival (Cohort 1,2,4)	To investigate antitumor efficacy of Nal-IRI. From initial medication to the date of death from any cause.	From initial medication to the date of death from any cause. Assessed up to 42 months.
Secondary	Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 (Cohort 1,2,3,4)	To assess the incidence and severity of adverse events in combination regimens.	Assessed except to 24 months.
Secondary	Pathological complete response rate (Cohort 3)	To investigate the effect of Nal-IRI.	After treatment and surgery, assessed up to 6 months.
Secondary	Event-free survival (Cohort 3)	To investigate the effect of Nal-IRI.	The time from enrollment to any event, including death, disease progression, or switch to a treatment, occurred first. Assessed up to 12 months.