Study of IP-001 Immunotherapy Combined with Microwave Ablation or Irreversible Electroporation for Treating Colorectal Liver Metastases

What this Trial Is About

Researchers are studying a new treatment approach for colorectal liver metastases CRLM, a type of cancer spread to the liver from colorectal cancer. This phase III clinical trial aims to find the best dose, safety, and immune response of a novel drug called IP-001 combined with ablative therapies, microwave ablation MWA or irreversible electroporation IRE. The goal is to enhance the bodys immune reaction against the tumor and improve survival outcomes in patients with metastatic colorectal cancer. The study is divided into three parts across two phases. Phase 1 uses a dose-escalation method to identify the maximum tolerated dose of IP-001 injected into the tumor after MWA. Phase 2 part 1 assesses the effectiveness of IP-001 following MWA in patients treated with curative intent. Phase 2 part 2 is a randomized trial comparing IP-001 combined with either MWA or IRE. Patients receive ablation of one to four liver metastases, followed by direct injection of IP-001 into the treated tumor areas. Participants will undergo imaging and laboratory tests before and after treatment to monitor safety and treatment effects. Researchers will track progression-free survival at one year, disease control rate at 16 weeks, and other outcomes such as overall survival, pain, and quality of life for up to five years. Blood samples will be taken at multiple time points after treatment to measure drug levels. The study includes safety monitoring and quality of life questionnaires during follow-up visits.

Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM