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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment involving fruquintinib, a PD-1 inhibitor called sintilimab, and chidamide for patients with metastatic colorectal cancer that is microsatellite stable (MSS) and has not responded to standard therapies. This phase 2 clinical trial plans to enroll 46 patients to study whether this combination can improve progression-free survival, along with other measures like overall survival and tumor response. Participants receive fruquintinib orally at 5 mg once daily for 14 days of each 21-day cycle. Sintilimab is given intravenously at 200 mg on the first day of each cycle, with the first infusion lasting 60 minutes and later infusions lasting 30 to 60 minutes. Chidamide is taken orally at 30 mg twice a week, with at least three days between doses. Treatment continues under this schedule and is monitored closely. During the trial, patients will be assessed for tumor size and disease progression, safety, and overall survival. Key tests include imaging according to RECIST v1.1 criteria and regular monitoring of blood counts and organ function. Patients must have measurable cancer lesions and good performance status to participate. The primary outcome is median progression-free survival measured over 24 months, with secondary outcomes including overall survival and response rates.
CONDITIONS
Brief 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 75 years or younger.
- Histologically confirmed colorectal adenocarcinoma.
- Unresectable locally advanced, unresectable recurrent, and/or metastatic disease after failure of two or more 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 3 months or longer.
- Adequate bone marrow, liver, and kidney function as defined by specific blood test thresholds.
- Negative pregnancy test for women of childbearing potential within 3 days before treatment.
- Use of highly effective contraception for all participants at risk of conception during and for 120 days after treatment.
You will not qualify if you...
- Palliative radiotherapy for colorectal cancer within 4 weeks before starting study treatment.
- Use of traditional Chinese medicine or herbal cancer treatments within 7 days before starting treatment.
- Symptomatic, untreated, or active central nervous system metastases.
- Severe uncontrolled medical conditions such as interstitial lung disease, epilepsy, or liver failure.
- Current or past autoimmune diseases or immunodeficiency disorders.
- History of certain lung diseases or active pneumonia.
- Severe infections requiring treatment within 4 weeks before treatment.
- Major surgery within 4 weeks before treatment or planned during the study.
- Significant heart conditions including congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, recent heart attack, or blood clots.
- Other cancers within 2 years before screening, except the current colorectal cancer.
- Prior treatment with immune checkpoint inhibitors or immunostimulatory agents within specified time frames.
- Active or chronic infections including HIV, active hepatitis B or C.
- For hepatitis B carriers, viral load must be controlled with mandatory antiviral therapy.
- Other conditions that may increase risk of early study termination.
- Recent use of systemic corticosteroids or immunosuppressants within 14 days before treatment, except for certain permitted uses.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation.
Participants receive Fruquintinib orally once daily on days 1-14 of each 21-day cycle, Sintilimab intravenously on day 1 of each cycle, and Chidamide orally twice weekly with at least 3 days between doses.
1 visit every 3 weeks
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
C
Chang Wang
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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