A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.

Launched by SUN YAT-SEN UNIVERSITY · Feb 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe certain treatments are for patients with advanced colorectal cancer, specifically those who have been treated with two chemotherapy drugs called oxaliplatin and irinotecan. The researchers want to understand the benefits and risks of different treatment options, including immunotherapy and targeted drugs, for patients who have either stopped these treatments due to worsening cancer or side effects, or who are receiving the same treatments again after a break.

To participate in this study, patients must have a confirmed diagnosis of colorectal cancer and have previously been treated with oxaliplatin and irinotecan but had to stop due to their cancer getting worse or due to side effects. Eligible participants should also be well enough to tolerate further treatment and expect to live for more than three months. Throughout the study, participants will not receive any new treatments; instead, researchers will collect information about their health and treatment responses. Everyone involved will be asked to give their written consent, ensuring they understand their participation and agree to follow-up on their health during the study.

Gender

ALL

Eligibility 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.