Combining Fruquintinib, Chidamide, and Sintilimab for Advanced Colorectal 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 evaluates the safety and efficacy of a combination treatment involving fruquintinib, chidamide, and sintilimab for patients with unresectable locally advanced or metastatic colorectal cancer that has not responded to standard therapies. The study focuses on patients with microsatellite stable or proficient mismatch repair colorectal cancer, building on previous findings from the CAPability-01 trial. Participants will receive these treatments to assess their effectiveness in improving patient outcomes in this challenging cancer setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Fully understand this study and voluntarily sign the informed consent form;
2. Age between 18-75 years inclusive;
3. Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;
4. Failure of standard second-line systemic treatment with measurable lesions;
5. Tumor tissue tested for microsatellite stability (MSS) or low microsatellite instability (MSI-L) by PCR, or confirmed pMMR by immunohistochemistry for DNA mismatch repair (MMR) protein (including MLH1, MSH2, MSH6, and PMS2 protein expression);
6. ECOG performance status of 0-2, with no deterioration within 7 days;
7. BMI≥18;
8. Expected survival ≥3 months;
9. Major organ functions meet the following requirements (no use of any blood components and growth factors within 14 days before enrollment):

   * Absolute neutrophil count ≥1.5×109/L, white blood cells ≥4.0×109/L;
   * Platelets ≥100×109/L;
   * Hemoglobin ≥90g/L;
   * Total bilirubin TBIL ≤1.5 times ULN;
   * ALT and AST ≤5 times ULN;
   * Urea/BUN and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min);
   * Left ventricular ejection fraction (LVEF) ≥50%;
   * Corrected QT interval by Fridericia's formula (QTcF) \<470 milliseconds.
   * INR ≤1.5×ULN, APTT ≤1.5×ULN.
10. Women of childbearing age must use effective contraception;
11. Good compliance and cooperation with follow-up.

Exclusion Criteria:

1. Unable to comply with the study protocol or procedures;
2. Pregnant or breastfeeding women;
3. Concurrent with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmias, and heart failure;
4. Previous treatment with small molecule tyrosine kinase inhibitors for metastatic disease;
5. Previous treatment with romidepsin;
6. Previous treatment with immune checkpoint inhibitors for metastatic disease;
7. Uncontrollable severe concurrent infections;
8. Acute myocardial infarction, acute coronary syndrome, or CABG within 3 months before the first treatment;
9. Subjects allergic to the study medication or any of its excipients;
10. Known human immunodeficiency virus (HIV) infection. Known clinically significant liver disease history, including viral hepatitis \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\>1×10\^4 copies/mL or \>2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA positive (\>1×10\^3 copies/mL)\];

12\. Patients whom the investigator deems inappropriate for inclusion in this study.

Where it's running

• China PLAGH
  Beijing, China Recruiting

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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.