RecruitingPhase 2NCT06709885

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

HDAC Inhibitor Combination With Immunochemotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer: A Multicenter, Double-arm, Phase II Randomized Controlled Study

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Enrollment

100 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Colon Adenocarcinoma

Summary

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?

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination of drugs — including a type called an HDAC inhibitor — alongside standard chemotherapy and immunotherapy given before surgery for locally advanced colon cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with colon cancer (adenocarcinoma) confirmed by biopsy - Your cancer is advanced locally (Stage T3 high-risk or T4 based on imaging) - Your tumor is in the colon (lower edge more than 12 cm from the anus) - You have not had any prior cancer treatment - You are in good general health **You may NOT be eligible if...** - Your tumor is causing a blockage, perforation, or uncontrolled bleeding - You have already received cancer treatment (chemo, radiation, etc.) - Your organ function (liver, kidney, bone marrow) does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChidamide + Tislelizumab + chemotherapy (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

DRUGCapeOX

4 cycles (q3w; Day1 Oxaliplatin, 130mg/m2, iv.gtt; Day1-Day14, capecitabine, 850-1000mg/m2, BID, PO. ） Post-operation 4 cycles of Capeox

Locations(1)

Daping Hospital， Third Military Medical University

Chongqing, Chongqing Municipality, China

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NCT06709885

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