Actively Recruiting
Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
Led by Peking University · Updated on 2024-06-05
933
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma diagnosed with unresectable metastatic disease (Cohort 1)
- Known to be pMMR/MSS or MMR/MS status unknown (Cohorts 1, 2, 3)
- Prior first-line systemic oxaliplatin- and fluorouracils-based therapy for metastatic disease progressed (Cohort 1)
- No prior irinotecan or liposomal irinotecan during metastatic disease treatment (Cohort 1)
- Scheduled to receive Nal-IRI plus fluorouracils or IRI plus fluorouracils chemotherapy as second-line therapy (Cohort 1)
- Patients with unresectable metastatic colorectal adenocarcinoma (Cohort 2)
- Received 3 or fewer lines of previous metastatic treatment (Cohort 2)
- Progressed after treatment with an irinotecan-containing regimen (Cohort 2)
- No previous treatment with liposomal irinotecan and scheduled for systemic Nal-IRI chemotherapy as palliative treatment (Cohort 2)
- At least one measurable lesion per RECIST v1.1 (Cohorts 2, 4)
- High-risk synchronous liver metastatic colorectal adenocarcinoma with 5 or fewer liver metastases, confirmed by histopathology or cytopathology, and planned resection (Cohort 3)
- Scheduled to receive Nal-IRI plus oxaliplatin plus fluorouracils chemotherapy as neoadjuvant therapy (Cohort 3)
- Non-pancreatic and non-colorectal cancer patients confirmed by histopathology or cytology (Cohort 4)
- Received at least one systemic treatment for unresectable disease (Cohort 4)
- Plan to receive systemic treatment containing Nal-IRI (Cohort 4)
You will not qualify if you...
- Planned treatment with immune checkpoint inhibitors during chemotherapy (Cohorts 1-4)
- Known allergy to irinotecan or liposomal irinotecan and its excipients (Cohorts 1-4)
- Female patients who are pregnant or breastfeeding (Cohorts 1-4)
- Other conditions deemed by the investigator to make the patient ineligible for enrollment (Cohorts 1-4)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Lin Shen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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