ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the best treatment approach for patients with liver metastases from colorectal cancer who have had surgery to remove these tumors. It specifically looks at whether a strategy of "watching and waiting" is just as effective as receiving chemotherapy after surgery for patients whose blood tests show no signs of cancer (known as ctDNA-negative). Participants will be randomly assigned to either receive chemotherapy or to be monitored closely without immediate treatment, and the researchers will compare how well both groups do over the next few years.

To be eligible for this trial, participants must be between 18 and 75 years old, have had surgery for their liver cancer, and have tested negative for ctDNA after the surgery. They should also be in good overall health and able to understand the study and give their consent. Throughout the trial, participants can expect regular check-ups and tests to monitor their health and the effectiveness of the treatment they receive. This study aims to provide valuable insights into whether some patients can safely avoid chemotherapy and still have good outcomes after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
• • 2. Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
• • 3. Patients with negative ctDNA after surgery;
• • 4. ASA grade \<IV and/or ECOG performance status score ≤ 2;
• • 5. Have sufficient understanding of the study and voluntarily sign an informed consent form.
• Exclusion Criteria:
• • 1. Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
• • 2. Patients with a history of other malignancies;
• • 3. Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
• • 4. Patients who are allergic to any component in the study;
• • 5. Patients who have received other tumor-related investigational drug therapy;
• • 6. Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
• • 7. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
• • 8. Patients with a history of severe mental illness;
• • 9. Pregnant or lactating women;
• • 10. Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.