Actively Recruiting
HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer
Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2024-11-29
100
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
D
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead Sponsor
S
Southwest Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent to participate in the study
- Diagnosed with colon cancer assessed as high-risk T3 or T4 by abdominal contrast-enhanced CT or abdominopelvic MRI
- Adenocarcinoma of the colon confirmed by tissue examination
- At least 18 years old, any gender
- Primary tumors without complications like perforation, obstruction, or bleeding that cannot be relieved by intervention
- Tumor located more than 12 cm from the anus
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver, kidney, and blood clotting function based on lab tests
- No prior anti-cancer treatments including chemotherapy, radiotherapy, or surgery
You will not qualify if you...
- Allergy to monoclonal antibodies, HDAC inhibitors, or capecitabine
- Previous or current treatment targeting tumor immunity mechanisms, immunosuppressive drugs, systemic hormonal drugs within 2 weeks before study drug use
- Recent live attenuated vaccine within 4 weeks before study drug use
- Major surgery or severe trauma within 4 weeks before study drug use
- Recent systemic non-specific immunomodulatory therapy or Chinese herbal medicines with anti-tumor effects within 2 weeks before study drug use
- Active or past autoimmune diseases such as interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism
- Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status
- Uncontrolled heart disease or symptoms
- Severe infection within 4 weeks before study drug use, active tuberculosis
- Active hepatitis B or C infection
- Other malignant tumors diagnosed within the past 8.5 years, except certain treated skin or cervical cancers
- Pregnant or breastfeeding women
- History of immunodeficiency including positive HIV, acquired or congenital immunodeficiency, or history of organ or bone marrow transplantation
- Other serious diseases or conditions that affect safety or compliance, including mental illness, alcoholism, drug abuse, or social factors as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Daping Hospital， Third Military Medical University
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
Research Team
F
fan li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here