NCT07927075Enrolling by invitationPhase 2/3
Evaluating the Efficacy of Chidamide in Advanced Refractory Colorectal Cancer With High SULF1 Expression
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
Previous studies have shown that HDAC inhibitors can inhibit SULF1 expression in CAFs. Chidamide, an HDAC inhibitor widely used in clinical practice, has demonstrated good efficacy in advanced breast cancer. Our retrospective study found that the higher the proportion of breast cancer patients with high fibroblast SULF1 expression, the more effective chidamide treatment was. Currently, the third-line treatment for advanced colorectal cancer consists of oral regorafenib or fruquintinib, but their median progression-free survival is only 2.3 and 3.7 months, respectively, and they are associated with significant adverse reactions such as rash, hypertension, and hyperbilirubinemia. The incidence of colorectal cancer continues to increase globally and in Asia; despite advances in advanced treatment, there remains a high unmet medical need, particularly for patients with refractory metastatic colorectal cancer. Chidamide is currently mainly used to treat relapsed or refractory peripheral T-cell lymphoma. Previous clinical studies in China and abroad have found that it also has good efficacy against various malignant tumors, including esophageal cancer, gastric cancer, lung cancer, nasopharyngeal carcinoma, breast cancer, liver cancer, cervical cancer, and leukemia. In summary, the proposed study evaluating the efficacy of chidamide in advanced refractory colorectal cancer with high SULF1 expression has important therapeutic value and high feasibility, supported by solid preliminary data. The objective of this study is to conduct a prospective, single-arm study in subjects with SULF1-high advanced colorectal cancer who have received at least 2 prior lines of standard therapy, to observe the efficacy and safety of chidamide. We hope this study will further clarify whether chidamide, a SULF1 inhibitor, can improve disease response rates, prolong response duration and survival time, and provide patients with advanced disease an opportunity to regain effective treatment.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 17 (estimated)
- First submitted
- 4 Nov 2026
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07927075
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 17
- From 1 Jun 2023 to the primary completion date, 1 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced colorectal cancer that has high SULF1 in the tumor and has already been treated with at least two standard drug regimens. All take chidamide by mouth.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Adenocarcinoma of the colon or rectum with distant spread or locally advanced and not removable by surgery. At least one measurable tumor on scan. Daily activity level (ECOG) of 0-1. Expected survival of at least 12 weeks.
- Earlier treatment
- Must have had at least two earlier standard treatment regimens, including fluorouracil, oxaliplatin and irinotecan. No local treatment (surgery, intervention, radiotherapy) planned within 2 months.
- Biomarker or test result
- High SULF1 expression in the tumor, confirmed by immunohistochemistry
Main reasons for not taking part
- Severe infection, bowel obstruction, active bleeding or perforation needing emergency surgery or a stent
- Another active cancer (some exceptions apply)
- Known HIV infection, or active hepatitis B or hepatitis C
- Serious heart problems, such as heart failure class II or higher or a heart attack within 12 months
- Pregnant women, minors and other vulnerable groups
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1）Patients with severe infection, obstruction, active bleeding, or perforation requiring emergency surgery or stent placement.
- 2）History of prior or concurrent other active malignancies (except malignancies that have been curatively treated with no recurrence for more than 5 years, or carcinoma in situ that can be cured with adequate treatment).
- 3）Major surgery such as laparotomy, thoracotomy, or laparoscopic organ resection, or severe trauma within the previous 2 weeks.
- 4）Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months before study enrollment.
- 5）Thrombotic or embolic events within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or deep vein thrombosis.
- 6）New York Heart Association (NYHA) class II or higher congestive heart failure.
- 7）Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or hepatitis C.
- 8）Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea.
- 9）Any unresolved CTCAE grade 2 or higher toxicity caused by prior treatment (except anemia, alopecia, and skin pigmentation).
- 10）Known or suspected history of allergy to any relevant drug used in the study.
- 11）Patients scheduled to undergo local treatment (surgery, intervention, radiotherapy, etc.) in the near future (within 2 months).
- 12）Any medical condition that is unstable or may affect patient safety and study compliance.
- 13）Radiotherapy within <4 weeks before the first dose of study drug, or chemotherapy, biological therapy, endocrine therapy, or small-molecule targeted therapy before the first dose of study drug (enrollment allowed if washout ≥5 half-lives from the first dose of study drug).
- 14）Insufficient hematopoietic function or organ function (correction with blood products such as transfusion within ≤14 days before the first dose of study drug is not allowed).
- 15）Vulnerable populations, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterate individuals, etc.
Who the study is looking for
- This study plans to enroll patients diagnosed with advanced colorectal cancer who are treated at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.
- Age ≥18 years.
- Voluntarily participate in this study and sign the informed consent form.
- Confirmed histological evidence of colon or rectal adenocarcinoma.
- ECOG performance status score of 0-1.
- Tumor SULF1 high expression confirmed by immunohistochemistry.
- Distant metastasis or unresectable locally advanced colon or rectal adenocarcinoma confirmed by CT or MR evaluation, and according to RECIST v1.1 criteria, at least one measurable lesion confirmed by independent central imaging review, and after multidisciplinary discussion, it is considered that local treatment (surgery, intervention, radiotherapy, etc.) will not be performed currently or in the near future (within 2 months).
- Patients with metastatic colorectal cancer who have received at least two prior lines of standard regimen therapy, including fluorouracil, oxaliplatin, and irinotecan.
- The following laboratory test values obtained within 7 days before treatment on Day 1 of each treatment cycle, with adequate organ function:
- Hemoglobin ≥90 g/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, serum total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase ≤2×ULN, alanine aminotransferase ≤3×ULN, serum creatinine ≤1.5×ULN.
- Willing and able to comply with the study protocol and visit schedule.
- Expected survival of at least 12 weeks.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine | Hangzhou | China | Unknown status |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.