HDAC Inhibitor Combination with Immunochemotherapy in the Neoadjuvant Treatment of PMMR Locally Advanced Colon Cancer: a Multicenter, Double-arm, Phase II Randomized Controlled Study
The purpose of this clinical trial is to learn the safety and efficacy of HDAC inhibitors in combination with neoadjuvant immunochemotherapy compared to neoadjuvant therapy in the treatment of locally advanced colon cancer. The main questions it aims to answer are: Can HDAC inhibitors combined with neoadjuvant immunochemotherapy improve the rate of pCR and complete resection in patients? Are HDAC inhibitors combined with neoadjuvant immunochemotherapy safe and reliable? Does the combination of HDAC inhibitors and neoadjuvant immunochemotherapy achieve a better long-term prognosis than neoadjuvant therapy?
• Signed written informed consent to voluntarily join this study
• Patients with colon cancer who are assessed by abdominal contrast-enhanced CT/abdominopelvic MRI as high-risk T3 (tumor destroys muscle wall and extends to pericolonic fat, protruding more than 5 mm into adjacent mesenteric fat) or T4 (tumor penetrates the visceral peritoneal surface or directly invades or adheres to adjacent organs or structures).
• Adenocarcinoma of the colon confirmed by histopathological examination.
• At least 18 years old, male or female.
• Uncomplicated primary tumors (Perforation ； obstruction and bleeding that cannot be relieved by intervention)
• The lower edge of the tumor is more than 12cm away from the anus.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate bone marrow, liver, renal, and coagulation function as assessed by the laboratory as required by the protocol
• Have not received any anti-tumor therapy for cancer in the past, including radiotherapy, chemotherapy, surgery, etc.;