Study of HDAC Inhibitors Combined With Immunochemotherapy Versus Chemotherapy Alone in Treating Adults With Locally Advanced Colon Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining HDAC inhibitors with neoadjuvant immunochemotherapy compared to neoadjuvant therapy alone in treating locally advanced colon cancer with proficient mismatch repair pMMR. The study aims to determine whether this combination improves the rate of complete pathological response pCR, complete tumor removal, and long-term outcomes for patients. This is a phase II randomized controlled trial sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Participants are randomly assigned to one of two treatment groups. One group receives four cycles of combination therapy every three weeks, including oxaliplatin, tislelizumab, chidamide, and capecitabine, followed by surgery and then four additional cycles of CapeOX chemotherapy. The other group receives four cycles of the CapeOX regimen alone every three weeks, followed by surgery and then four more cycles of CapeOX. Treatments involve intravenous infusions and oral medications taken on specified days within each cycle. During the study, patients will be closely monitored through imaging and laboratory tests, with the primary outcome being the rate of complete pathological response evaluated about 12 weeks after surgery. Secondary outcomes include disease-free survival, overall survival, major pathological response, tumor down-staging, curative resection rates, postoperative complications, and adverse effects over a follow-up period of up to three years. Participation involves regular treatment visits, surgery, and long-term follow-up assessments to evaluate the safety and effectiveness of the treatment combinations.

HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer