Actively Recruiting
Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer
Led by Dai, Guanghai · Updated on 2024-11-20
46
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate by signing informed consent
- Age between 18 and 75 years inclusive
- Histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma
- Failure of standard second-line systemic treatment with measurable lesions
- Tumor tested for microsatellite stability (MSS) or low microsatellite instability (MSI-L), or confirmed proficient mismatch repair (pMMR)
- ECOG performance status of 0 to 2 without deterioration within 7 days
- Body mass index of at least 18
- Expected survival of at least 3 months
- Adequate major organ function as defined by specific blood counts and biochemical values
- Women of childbearing potential must use effective contraception
- Ability to comply with study procedures and follow-up
You will not qualify if you...
- Inability to follow the study protocol or procedures
- Pregnant or breastfeeding women
- Uncontrolled hypertension, coronary artery disease, arrhythmias, or heart failure
- Prior treatment with small molecule tyrosine kinase inhibitors for metastatic disease
- Prior treatment with romidepsin
- Prior treatment with immune checkpoint inhibitors for metastatic disease
- Severe uncontrolled infections
- Recent acute myocardial infarction, acute coronary syndrome, or coronary artery bypass graft within 3 months
- Allergy to study medications or their components
- Known HIV infection or significant liver disease including active hepatitis B or C infection
- Any condition deemed unsuitable for study participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
China PLAGH
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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