Actively Recruiting
A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
Led by Sun Yat-sen University · Updated on 2023-02-16
500
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective observational study is to learn about the treatment decisions in advanced colorectal cancer treated with oxaliplatin and irinotecan. The main questions:1. learn about the efficacy and safety of immunotherapy or targeted drugs or other chemotherapy for patients treated with oxaliplatin and irinotecan（non-retreatment/rechallenge group，NR group）. 2. learn about the efficacy and safety of oxaliplatin or irinotecan for patients treated with oxaliplatin and irinotecan (retreatment/rechallenge group, RT/RC group). 3. compare the efficacy and safety of various treatment regimens for patients treated with oxaliplatin and irinotecan. This study will only collect the clinical data of patients, without any intervention, in the treatment services. All participants will be provided written informed consent as per the Declaration of Helsinki principles.
CONDITIONS
Official Title
A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed colorectal adenocarcinoma
- Previously treated with oxaliplatin and irinotecan but discontinued due to progression or intolerable toxicity
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Predicted survival of more than 3 months
- Main organ function adequate to tolerate next treatment as judged by investigators
- Signed informed consent
- Agree to survival follow-up
You will not qualify if you...
- Previous treatment with regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, or targeted/immunotherapy for HER2 amplification, BRAF V600E mutation, or NTRK gene fusion
- Previously retreated or rechallenged with oxaliplatin or irinotecan after progression
- Participation in another interventional clinical study currently, except in follow-up stage
- Planned use of treatment including regorafenib, furquintinib, or trifluridine but unable to take oral drugs due to swallowing issues, chronic diarrhea, or intestinal obstruction
- Refusal to use contraceptive measures during and 6 months after study treatment
- History of other primary malignant tumors except treated non-melanoma skin cancer, lentigo maligna, or carcinoma in situ without recurrence
- History of allogeneic organ or hematopoietic stem cell transplantation
- Serious diseases that risk patient safety or study completion
- Any other condition judged unsuitable for clinical research
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
D
Dongsheng Zhang, MD., phD.
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
3
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