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

RECRUITINGPHASE2

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

A Prospective Single-arm Phase Ib/II Study on the Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer

NCT06685276•Dai, Guanghai

View on ClinicalTrials.gov

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. CAPability-01 trial investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide with or without the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab in patients with unresectable chemotherapy-refractory locally advanced or metastatic microsatellite stable/proficient mismatch repair (MSS/pMMR) colorectal cancer. Based on the previous findings of CAPability-01, we will further evaluate the efficacy and safety of sintilimab and chidamide in combination with fruquintinib in the same setting.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+10 more criteria

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 \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\>1×10\^4 copies/mL or \>2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA positive (\>1×10\^3 copies/mL)\];
+1 more criteria

Locations (1)

China PLAGH

Beijing, China

Key Dates

Start Date

August 16, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

November 20, 2024

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer Metastatic

Interventions

Fruquintinib

DRUG

Sintilimab

DRUG

Chidamide

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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