A Phase 2 interventional study of Chidamide + Tislelizumab + chemotherapy (CapeOX ) and CapeOX in Colon Adenocarcinoma, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Phase 2, Interventional, and Treatment
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?
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 115 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Has received or is receiving any of the following treatments in the past:
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)
Drug: Chidamide + Tislelizumab + chemotherapy (CapeOX )
4 cycles Capeex (q3w; Day1 Oxaliplatin, 130mg/m2, iv.gtt; Day1-Day14, capecitabine, 850-1000mg/m2, BID, PO. ）
Drug: CapeOX
Chidamide + 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
4 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
Time frame: The pCR rate will be evaluated after surgery, an average of 12 weeks
Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first.
Time frame: 3 years
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
Time frame: 3 years
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
Time frame: From enrollment to 12 Weeks of treatment end
Curative resection
Curative resection defined as complete tumor resection with all margins being negative.
Time frame: From enrollment to 12 Weeks of treatment end
ORR
Objective response is defined as a complete response (CR) or response (PR) according to RECIST v1.1
Time frame: From enrollment to 12 Weeks of treatment end
Down-staging of primary tumors
Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (7th version).
Time frame: From enrollment to 12 Weeks of treatment end
Postoperative complications
Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Time frame: 3 years
Grade 3-4 adverse effects rate
Rate of chemotherapy andHDACI and immunotherapy related severe adverse events
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years
Plan to share: No
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University