Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer

Phase 2

Recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Fruquintinib; Drug: Sintilimab; Drug: Chidamide

• Registration Number: NCT06685276
• Lead Sponsor: Dai, Guanghai

Brief Summary

The prognosis of most patients with unresectable locally advanced or metastatic colorectal cancer (CRC) remains poor despite the advancements in chemotherapy and target therapy.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-08-16
• Status Verified: 2024-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

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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)];

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Fruquintinib	Fruquintinib Sintilimab Chidamide Treatments are administered until disease progression or toxicity intolerable.
Study arm	Sintilimab	Fruquintinib Sintilimab Chidamide Treatments are administered until disease progression or toxicity intolerable.
Study arm	Chidamide	Fruquintinib Sintilimab Chidamide Treatments are administered until disease progression or toxicity intolerable.

Primary Outcome Measures

Name	Time	Method
Progress-free Survival(PFS)	24 months	The time from enrollment until tumor progression or death from any cause, whichever occurred first

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	24 months	The proportion of patients with a PR or CR
Overall Survival (OS)	24 months	The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Disease control rate (DCR)	24 months	The proportion of patients with a PR, CR, or SD
Duration of response (DoR)	24 months	For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first

Trial Locations

Locations (1)

China PLAGH; 🇨🇳 Beijing, China