RecruitingPhase 2NCT06685276

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


Sponsor

Dai, Guanghai

Enrollment

46 participants

Start Date

Aug 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination (fruquintinib, chidamide, and sintilimab) in people with advanced colorectal cancer that hasn't responded to standard treatments and is classified as microsatellite stable (MSS) — a type that typically doesn't respond well to immunotherapy alone. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with advanced or metastatic colorectal cancer (confirmed by biopsy) - Your cancer has not responded to at least two prior rounds of standard treatment - Your tumor has been tested and confirmed as MSS or pMMR (a specific molecular profile) - Your heart, liver, and kidney function meet the required levels - You are physically functional (ECOG 0–2) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have uncontrolled heart disease or high blood pressure - You have previously been treated with tyrosine kinase inhibitors or immune checkpoint drugs for metastatic disease - You are allergic to any of the study drugs - You have active HIV or active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib

Fruquintinib: 5mg qd, po, 2 weeks on/1 week off, q3w, or 3mg qd, po, q3w.

DRUGSintilimab

Sintilimab: 200mg, iv, d1, q3w.

DRUGChidamide

Chidamide: 30mg/m2, po, biw.


Locations(1)

China PLAGH

Beijing, China

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NCT06685276


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