An observational study in Colorectal Cancer and Solid Tumor, sponsored by Peking University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Peking University · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 933 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
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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.
Cohort 1:
Cohort 2:
Cohort 3:
Cohort 4:
Exclusion Criteria:
Cohort 1-4:
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
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
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
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
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.
Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)
To investigate the safety with Nal-IRI and IRI.
Time frame: 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.
Time frame: 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.
Time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
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.
Time frame: 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)
To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete , partial or stable response (SD) assessed by RECIST v1.1.
Time frame: 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)
To investigate antitumor efficacy of study. From initial medication to the date of first documented progression or end of medication, whichever came first.
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.
Overall survival (Cohort 1,2,4)
To investigate antitumor efficacy of Nal-IRI. From initial medication to the date of death from any cause.
Time frame: 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)
To assess the incidence and severity of adverse events in combination regimens.
Time frame: Assessed except to 24 months.
Pathological complete response rate (Cohort 3)
To investigate the effect of Nal-IRI.
Time frame: After treatment and surgery, assessed up to 6 months.
Event-free survival (Cohort 3)
To investigate the effect of Nal-IRI.
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.
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