What this Trial Is About

Researchers are evaluating a combined treatment approach for patients with colorectal cancer (CRC) whose disease has progressed after first-line therapy. This study involves personalized tumor neoantigen-loaded dendritic cell (DC) vaccines alongside conventional second-line therapies, aiming to assess treatment effectiveness and safety, including objective response rate (ORR), disease control rate (DCR), adverse events, progression-free survival, and overall survival. Participants will receive a tailored treatment plan combining conventional second-line therapies—such as chemotherapy, targeted drugs, and/or PD-1 inhibitors—with a personalized neoantigen-loaded DC vaccine. The vaccine treatment includes a primary phase of six doses administered subcutaneously over several weeks and a boost phase of four doses spaced three weeks apart. The total vaccine treatment period lasts 21 weeks, with conventional therapy schedules determined by the attending physician. After treatment, participants are followed every six weeks until study completion. During the study, participants undergo regular assessments including blood tests, physical exams, performance status evaluations, imaging scans (CT/MRI, X-ray), and laboratory tests at each follow-up visit. Researchers monitor treatment response, disease control, and safety outcomes over an average of 32 weeks. The study enrolls patients aged 18 to 70 with measurable CRC lesions and aims to ensure participant safety through continuous monitoring and evaluations.

Neoantigen-loaded DC Vaccine and Conventional Second-line Therapy for CRC Progressed After First-line Treatment