Actively Recruiting
A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
Led by The First Hospital of Jilin University · Updated on 2025-05-20
46
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, single-center clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with a PD-1 inhibitor and chidamide in patients with refractory MSS-type metastatic colorectal cancer (mCRC). A total of 46 patients are planned to be enrolled, with the primary endpoint being median progression-free survival (mPFS). Secondary endpoints include median overall survival (mOS), objective response rate (ORR), and safety.
CONDITIONS
Official Title
A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to comply with the study protocol
- Age 18 years or older and up to 75 years
- Histologically confirmed colorectal adenocarcinoma
- Unresectable locally advanced, unresectable recurrent, and/or metastatic disease after failure of at least 2 prior lines of standard therapy
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, and renal function as specified
- Negative pregnancy test within 3 days prior to first dose for women of childbearing potential
- Use of highly effective contraception during treatment and for 120 days after last dose of study drug
You will not qualify if you...
- Palliative radiotherapy for colorectal cancer within 4 weeks prior to study treatment
- Use of traditional Chinese medicine or herbal preparations for cancer control within 7 days before study treatment
- Symptomatic, untreated, or actively progressing central nervous system metastases
- Severe uncontrolled comorbidities such as interstitial lung disease, epilepsy, or hepatic failure
- Current or history of autoimmune diseases or immunodeficiency disorders
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or active pneumonia on screening
- Severe chronic or active infection requiring treatment within 4 weeks prior to study
- Major surgery within 4 weeks before study treatment or planned during study
- Significant cardiovascular disease including symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, recent myocardial infarction, or recent thromboembolism
- History of other malignancies within 2 years except the cancer under investigation
- Prior immune checkpoint inhibitor therapy or immunostimulatory agents within specified time frames
- Chemotherapy, immunotherapy, or investigational therapy within 14 days before study treatment
- Active or chronic infections including HIV, active hepatitis B or C, or related history
- HBV carriers must have low viral load and receive antiviral therapy
- HCV-seropositive patients must have negative RNA for enrollment
- Conditions increasing risk of premature study termination as judged by investigator
- Use of systemic corticosteroids or immunosuppressants within 14 days prior to first dose except permitted inhaled or topical corticosteroids and low-dose adrenal replacement therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
C
Chang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here