Actively Recruiting
Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC
Led by Sun Yat-sen University · Updated on 2023-03-14
176
Participants Needed
12
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy in subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy. The primary purpose is to compare the progression-free survival (PFS) of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy for colorectal cancer, with a planned enrollment of 176 subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy.
CONDITIONS
Official Title
Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with locally advanced unresectable or metastatic colorectal adenocarcinoma confirmed by pathology or cytology
- Microsatellite stability (MSS) or low microsatellite instability (MSI-L) confirmed by PCR or immunohistochemistry showing no loss of MMR proteins
- Failed first-line oxaliplatin-containing therapy with evidence of disease progression or intolerance leading to treatment discontinuation
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Signed informed consent and able to follow study procedures
- Aged between 18 and 75 years
- Expected survival time of at least 18 weeks
- Agree to use effective contraception during treatment and for 6 months after
- Adequate organ and bone marrow function based on recent laboratory tests
You will not qualify if you...
- Previous treatment with anti-PD-1/PD-L1 antibodies, HDAC inhibitors, or irinotecan
- Use of investigational drugs within 4 weeks before study treatment
- Participation in another interventional clinical trial
- Recent antitumor therapy within 3 weeks prior to study treatment
- Radiotherapy within 4 weeks prior to study treatment or unresolved radiotherapy-related toxicities
- Use of immunosuppressive drugs within 4 weeks prior to study treatment (with some exceptions)
- Recent live attenuated vaccine or planned vaccination during study
- Major surgery or unhealed wounds within 4 weeks prior to study treatment
- Unresolved toxicities from prior cancer therapies above grade 1
- Active or symptomatic brain metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment within 2 years
- Active tuberculosis or recent anti-tuberculosis treatment
- Interstitial lung disease needing steroid therapy
- Active hepatitis B or C infection
- HIV or syphilis infection
- Severe or uncontrolled infections within 4 weeks prior to study treatment
- Significant malnutrition or recent need for intravenous nutrition
- Symptomatic heart failure, unstable arrhythmias, or uncontrolled hypertension
- Recent arterial thromboembolic events or serious thromboembolism
- Severe liver disease or history of gastrointestinal perforation, fistula, or significant bowel disease
- Frequent severe diarrhea at baseline
- Known allergies to study drugs or related treatments
- Uncontrolled metabolic or systemic diseases that increase risk
- History of bleeding disorders or recent life-threatening bleeding
- High risk of bleeding as assessed by investigator
- Recent cerebrovascular accidents
- Recent use of high-dose aspirin, NSAIDs, anticoagulants, or thrombolytics
- Presence of symptomatic pleural fluid, ascites, or pericardial effusion
- History of other malignancies within 2 years except certain treated skin or in situ cancers
- History of allogeneic organ or stem cell transplantation
- Known allergy to monoclonal antibodies
- Pregnancy or lactation
- History of alcohol or drug abuse
- Other medical or psychiatric conditions that could increase study risk or interfere with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
The First People's Hospital of Foshan
Foshan, Guangdong, China
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
4
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
5
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Not Yet Recruiting
6
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
8
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
9
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
10
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
11
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Not Yet Recruiting
12
The First Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
R
Ruihua Xu, MD
CONTACT
F
Feng Wang, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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