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.
History of previous allergy to monoclonal antibodies, any component of HDACi, and capecitabine;
Received any treatment against the mechanism of action of tumor immunity, such as immunization, HDACi, etc.
Immunosuppressive drugs, or systemic hormonal drugs within 2 weeks prior to the first use of the study drug to achieve immunosuppressive purposes
Receipt of a live attenuated vaccine within 4 weeks prior to the first use of study drug;
Parallel
Chidamide + Tislelizumab + chemotherapy (CapeOX )
DrugChidamide + Tislelizumab + chemotherapy (CapeOX regimen): 4 cycles of combination therapy (q3w; Day1 Oxaliplatin, 130mg/m2, iv.gtt; tislelizumab, 200mg/m2 iv.gtt; Day1,4,8,11Chidamide 20 mg BIW,PO; Day1-Day14, capecitabine 850-1000mg/m2, BID, PO) ；After completing the surgery, Post-operation 4 cycles of Capeox
CapeOX
Drug4 cycles (q3w; Day1 Oxaliplatin, 130mg/m2, iv.gtt; Day1-Day14, capecitabine, 850-1000mg/m2, BID, PO. ） Post-operation 4 cycles of Capeox
pCR
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first.
Overall survival (OS)
Defined as the time from randomization to date of death due to any cause according to RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause
MPR
After neoadjuvant therapy, the percentage of residual viable tumor cells in the tumor bed ≤ 10%. Regardless of whether there are viable tumor cells left in the lymph nodes
Curative resection
Curative resection defined as complete tumor resection with all margins being negative.
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead sponsor
Southwest Hospital, China
Collaborator
Xinqiao Hospital of Chongqing
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Chongqing Medical University
Collaborator
Chongqing University Cancer Hospital
Collaborator
Chongqing General Hospital
Collaborator
Chongqing Traditional Chinese Medicine Hospital
Collaborator
Chongqing Shapingba District People's Hospital
Collaborator
Chongqing Seventh People's Hospital
Collaborator
Chongqing Renji Hospital, University of Chinese Academy of Sciences
Collaborator
The 13th People's Hospital of Chongqing
Collaborator
