Using HDAC inhibitors with chemoimmunotherapy for advanced colon cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of combining HDAC inhibitors with neoadjuvant immunochemotherapy in patients with locally advanced colon cancer. The study aims to determine if this combination can improve the rate of pathological complete response (pCR) and complete tumor resection compared to standard neoadjuvant therapy. It also seeks to evaluate the long-term prognosis and safety of this treatment approach. Participants will receive Chidamide and Tislelizumab alongside chemotherapy regimens like CapeOX.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent to voluntarily join this study
2. 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).
3. Adenocarcinoma of the colon confirmed by histopathological examination.
4. At least 18 years old, male or female.
5. Uncomplicated primary tumors (Perforation ； obstruction and bleeding that cannot be relieved by intervention)
6. The lower edge of the tumor is more than 12cm away from the anus.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Adequate bone marrow, liver, renal, and coagulation function as assessed by the laboratory as required by the protocol
9. Have not received any anti-tumor therapy for cancer in the past, including radiotherapy, chemotherapy, surgery, etc.;

Exclusion Criteria:

1. History of previous allergy to monoclonal antibodies, any component of HDACi, and capecitabine;
2. Has received or is receiving any of the following treatments in the past:

   1. Received any treatment against the mechanism of action of tumor immunity, such as immunization, HDACi, etc.
   2. Immunosuppressive drugs, or systemic hormonal drugs within 2 weeks prior to the first use of the study drug to achieve immunosuppressive purposes
   3. Receipt of a live attenuated vaccine within 4 weeks prior to the first use of study drug;
   4. Major surgery or severe trauma within 4 weeks prior to the first use of study drug;
   5. Receipt of systemic non-specific immunomodulatory therapy within 2 weeks prior to the first dose; Have received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks before the first dose.
3. Has any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism,
4. dMMR/MSI-H;
5. Presence of cardiac clinical symptoms or diseases that are not well controlled,
6. Severe infection (CTCAE \> grade 2) within 4 weeks prior to the first use of study drug, with active tuberculosis infection found by medical history or CT examination,
7. Presence of active hepatitis B, hepatitis C 8.5 years of diagnosis of other malignant tumors, (adequately treated basal cell carcinoma of the skin or squamous cell skin cancer or carcinoma in situ of the cervix, etc., can be considered for enrollment);

9\. Pregnant or lactating females; 10. As judged by the investigator, there are other factors that may lead to forced termination of the study, such as other serious diseases (including mental illnesses) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, and factors that may affect the safety or compliance of the subject.

11\. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency disorders, or have a history of organ transplantation or allogeneic bone marrow transplantation;

Where it's running

• Daping Hospital， Third Military Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: fan li, PhD
• Email: levinecq@163.com
• Phone: 18696539200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Postoperative ctDNA Monitoring to Predict Recurrence in Driver-Mutant Stage I-III Colon Cancer

  This study tests whether checking blood tumor DNA after surgery can predict if driver-mutant stage I-III colon cancer will come back.

  Recruiting Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07795528

• Adding tolecizumab to chemoimmunotherapy before surgery for locally advanced pMMR/MSS colon cancer

  We're testing whether adding tolecizumab (a PCSK9 blocker) to sintilimab plus CapeOX before surgery helps people with pMMR/MSS locally advanced colon cancer (cT3c or higher) achieve a complete tumor response.

  Recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Chongqing, Chongqing Municipality · NCT07468630

• Family genetics: who shares test results with relatives

  This study tests whether letting patients share genetic results with their relatives is as good as doctors sharing the results to help first-degree relatives get genetic testing for hereditary cancer risk.

  Recruiting at 362 sites Alliance for Clinical Trials in Oncology · Birmingham, Alabama and 364 other locations · NCT07143487

• Calderasib plus cetuximab and chemotherapy for KRAS G12C colorectal cancer

  This trial will test whether adding calderasib and cetuximab to mFOLFOX6 helps people with unresectable locally advanced or metastatic colorectal cancer that has a KRAS G12C mutation live longer without their cancer growing.

  Recruiting at 244 sites Phase 3 Merck Sharp & Dohme LLC · Phoenix, Arizona and 244 other locations · NCT06997497

• Testing a new stool test for colorectal cancer detection

  This study is testing a new stool test to see if it can help find colorectal cancer and advanced growths in people aged 45 and older who are at average risk.

  Recruiting Mainz Biomed · Morrisville, North Carolina · NCT06864338

• Elderly patients with metastatic colorectal cancer: first-line reduced-dose chemo plus targeted antibody

  This retrospective study looks at whether starting older patients (70+) on a reduced-dose doublet chemotherapy combined with a full-dose monoclonal antibody can be feasible in first-line treatment for metastatic colorectal cancer.

  Recruiting Ente Ospedaliero Ospedali Galliera · Genova, GE and 1 other locations · NCT06840977

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.