A Phase 2/3 interventional study of Oral chidamide treatment in Colorectal Cancer, sponsored by Sir Run Run Shaw Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Sir Run Run Shaw Hospital · Phase 2/3, Interventional, and Treatment
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 17 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The following laboratory test values obtained within 7 days before treatment on Day 1 of each treatment cycle, with adequate organ function:
≥90 g/L, ≥1.5×10⁹/L, count ≥75×10⁹/L, serum total ≤1.5× (ULN), ≤2×ULN, alanine aminotransferase ≤3×ULN, serum creatinine ≤1.5×ULN.
Exclusion Criteria:
1）Patients with severe infection, obstruction, active bleeding, or perforation requiring emergency surgery or stent placement.
2）History of prior or concurrent other active (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 ), pulmonary embolism, or deep vein thrombosis.
6） (NYHA) class II or higher congestive heart failure.
7）Known (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related disease, or active or .
8）Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea.
9）Any unresolved 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral chidamide treatment：The recommended adult dose is 30 mg (6 tablets) per administration, taken twice weekly, with an interval of no less than 3 days between the two doses (e.g., Monday and Thursday, Tuesday and Friday, Wednesday and Saturday). Take 30 minutes after breakfast. The total treatment duration is 12 months.
Drug: Oral chidamide treatment
The recommended adult dose is 30 mg (6 tablets) per administration, taken twice weekly, with an interval of no less than 3 days between the two doses (e.g., Monday and Thursday, Tuesday and Friday, Wednesday and Saturday). Take 30 minutes after breakfast. The total treatment duration is 12 months.
ORR
To evaluate the objective response rate (ORR) of chidamide (a SULF-1 inhibitor) in patients with metastatic colorectal cancer who have progressed after at least two prior lines of standard therapy (including fluoropyrimidines, irinotecan, and oxaliplatin
Time frame: 6 -12 months
OS
Overall Survival
Time frame: up to 5 years
PFS
Progression-Free Survival
Time frame: up to 5 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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