Phase III Trial Comparing Neoadjuvant Systemic Therapy Plus Repeat Local Treatment Versus Repeat Local Treatment Alone in Recurrent Colorectal Liver Metastases

What this Trial Is About

Researchers are evaluating treatment options for patients with recurrent colorectal liver metastases CRLM who have at least one locally treatable recurrence within 12 months after initial local treatment and no cancer outside the liver. The study aims to compare whether giving neoadjuvant systemic therapy before repeat local treatment improves overall survival compared to repeat local treatment alone. This phase III randomized controlled trial enrolls patients with good health status and considers specific tumor and genetic factors for grouping before treatment. Participants are randomly assigned to one of two groups the control group receives upfront repeat local treatment, while the intervention group receives 12 weeks of neoadjuvant systemic therapy followed by repeat local treatment. The systemic therapy includes up to 4 cycles of CAPOX or 6 cycles of FOLFOXFOLFIRI chemotherapy, possibly combined with bevacizumab. The choice of repeat local treatment, such as surgery or thermal ablation, is decided by local doctors based on each patients situation. During the study, patients will be monitored for up to 5 years, with assessments including overall survival, progression-free survival, treatment side effects, hospital stay length, pain levels, quality of life, and cost-effectiveness. Researchers will collect clinical data and evaluate safety outcomes after treatments. The total participation time includes treatment and long-term follow-up to understand the effects of these treatment approaches on patient outcomes.

COLLISION RELAPSE Trial