HDAC Inhibitor Combination with Chemoimmunotherapy in the Neoadjuvant Treatment of PMMR Locally Advanced Colon Cancer

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?

Conditions

• Colon Adenocarcinoma

Interventions

DRUG

Chidamide + 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

DRUG

CapeOX

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

Sponsors & Collaborators

• Southwest Hospital, China

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Chongqing Medical University

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• Chongqing General Hospital

  collaborator OTHER

• Chongqing Traditional Chinese Medicine Hospital

  collaborator OTHER

• Chongqing Shapingba District People's Hospital

  collaborator UNKNOWN

• Chongqing Seventh People's Hospital

  collaborator UNKNOWN

• Chongqing Renji Hospital, University of Chinese Academy of Sciences

  collaborator OTHER_GOV

• The 13th People's Hospital of Chongqing

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• fan Li, PhD · Third Military Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-15

Primary Completion

2025-09-30

Completion

2027-09-30

Countries

• China

Study Locations