Observational study on advanced colorectal cancer treatment with oxaliplatin and irinotecan
A Multi-center、Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
This study looks at how well different treatments work for people with advanced colorectal cancer who have already received oxaliplatin and irinotecan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | furoquintinib, furquintinib, chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05731336 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on treatment decisions for patients with advanced colorectal cancer who have been treated with oxaliplatin and irinotecan. It will assess the efficacy and safety of various treatment regimens, including immunotherapy, targeted drugs, and chemotherapy, in both non-retreatment and retreatment groups. The study will collect clinical data without any intervention, ensuring that all participants provide informed consent in accordance with ethical guidelines.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed colorectal adenocarcinoma who have been treated with oxaliplatin and irinotecan and have experienced disease progression or intolerable toxicity.
Not a fit: Patients who have previously been treated with specific targeted therapies or immunotherapies, or those currently participating in another interventional study, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective treatment strategies for advanced colorectal cancer, potentially improving patient outcomes.
How similar studies have performed: While this study focuses on a specific cohort, similar observational studies have provided valuable data on treatment efficacy in advanced cancers, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Phologically confirmed colorectal adenocarcinoma 2. Treated by oxaliplatin and irinotecan and discontinued due to progression or intolerable drug toxicity 3. ECOG 0-2 4. Predicted survival more than 3 months 5. Estimated by investigators that the main organ function is enough good to tolerate the next treatment plan. 6. Sign informed consent. 7. Agree to receive survival follow-up Exclusion Criteria: 1. Previously exposed to regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, or targeted drugs or immunotherapy for HER2 amplification, BRAF V600E mutation, and NTRK gene fusion. 2. Previously rechallenged or retreated by oxaliplatin or irinotecan after progression from chemotherapy regimens including oxaliplatin and irinotecan. 3. Participate in another interventional clinical study at the same time, unless in the follow-up stage of intervention study. 4. Proposed to use a treatment regimen containing regorafenib, furquintinib, and trifluridine, but has any problems obstacling oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction et al. 5. Disagree to take contraceptive measures during the study treatment period or within 6 months after the end of the study treatment period. 6. Has other primary malignant tumor history, unless non-melanoma skin cancer or lentigo maligna or carcinoma in situ with sufficient treatment and no disease recurrence. 7. Has the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 8. Has concomitant diseases that seriously endanger patient safety or affect patient completion of the study. 9. Has other problems that is not suitable for clinical research.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Dongsheng Zhang, MD., phD.
- Email: zhangdsh@sysucc.org.cn
- Phone: 86+020-87343795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.