Efficacy and Safety of DC-CIK Cell Therapy Combined With Epaglitovirizumab and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer

What this Trial Is About

Researchers are studying a new treatment for patients with advanced colorectal cancer who have not responded to second-line standard treatments. This research focuses on a combination approach that includes autologous DC-CIK cell immunotherapy, a domestic PD-1/CTLA-4 bispecific antibody called epaglitovirizumab, and the multi-target tyrosine kinase inhibitor regorafenib. The goal is to assess the effectiveness and safety of this triple therapy as a third-line treatment and to understand its immune-related mechanisms, especially for patients with microsatellite stable tumors who often do not respond to immune therapies alone. Participants will receive a combination therapy regimen consisting of epaglitovirizumab given intravenously at 5.0 mg/kg every 21 days, oral regorafenib at 120 mg daily for 21 days in each 28-day cycle with dose adjustments as needed, and DC-CIK cell therapy. The DC-CIK therapy involves collecting blood cells from patients, culturing and expanding DC and CIK cells, followed by subcutaneous injections of DC cells into lymph node areas four times and intravenous infusions of CIK cells three times over four treatment cycles. Treatment continues until disease progression, unacceptable side effects, withdrawal, new anti-tumor therapy, or up to two years. Throughout the study, participants will be monitored for response to treatment using RECIST 1.1 criteria and safety evaluations. Researchers will assess progression-free survival, objective clinical response, overall survival, duration of remission, and immune responses related to treatment. The study includes strict quality control and risk management, with ongoing safety monitoring and follow-up for up to two years. This comprehensive approach aims to improve outcomes for chemotherapy-resistant advanced colorectal cancer patients.

Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer.