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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Fully understand this study and voluntarily sign the informed consent form;

• Age between 18-75 years inclusive;

• Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;

• Failure of standard second-line systemic treatment with measurable lesions;

• 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);

• ECOG performance status of 0-2, with no deterioration within 7 days;

• BMI≥18;

• Expected survival ≥3 months;

• 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.

⁃ Women of childbearing age must use effective contraception;

⁃ Good compliance and cooperation with follow-up.

Locations
Other Locations
China
China PLAGH
RECRUITING
Beijing
Time Frame
Start Date: 2024-08-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 46
Treatments
Experimental: Study arm
Fruquintinib Sintilimab Chidamide~Treatments are administered until disease progression or toxicity intolerable.
Related Therapeutic Areas
Sponsors
Leads: Dai, Guanghai

This content was sourced from clinicaltrials.gov

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