Actively Recruiting
Safety and Efficacy of Pembrolizumab in Combination with Bevacizumab + CapeOX in the Neoadjuvant Treatment of RAS-mutated, BRAF Wild-type, Microsatellite-stabilized, Locally Advanced Colorectal Cancer
Led by yangjianjun · Updated on 2024-11-12
20
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated, BRAF wild-type, microsatellite-stabilized, locally advanced colorectal cancer. Methods and analysis: A prospective, open-label, single-arm, phase 2 clinical study protocol will enroll a total of 20 patients. The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer (LACRC) patients. Initially, 9 patients will be recruited in the Simon I phase, and if more than 1 patient achieves a pathological complete response (pCR), the study will proceed to the II phase. Recruit up to 20 patients in Phase II, and if more than 4 patients achieve pCR, the trial will be considered successful. All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine). The primary efficacy endpoint is the pathological complete response (pCR) of the cancer following neoadjuvant therapy. Secondary efficacy endpoints include major pathological response (MPR), objective response rate (ORR), and assessment of adverse events (AEs). Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital (Xijing Hospital)(KY20232402-F-1)
CONDITIONS
Official Title
Safety and Efficacy of Pembrolizumab in Combination with Bevacizumab + CapeOX in the Neoadjuvant Treatment of RAS-mutated, BRAF Wild-type, Microsatellite-stabilized, Locally Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed RAS mutation and BRAF wild-type status in locally advanced colorectal cancer by pathology or genetic testing
- ECOG Performance Status of 0 or 1
- No previous treatment for this cancer
- Microsatellite-stable tumor status
- Normal blood counts: WBC 4x10^9/L; neutrophils 1.5x10^9/L; platelets 100x10^9/L; hemoglobin 90 g/L
- Normal kidney function: serum creatinine 1.5 times upper normal limit or creatinine clearance above 60 mL/min
- Normal liver function: bilirubin 1.5 times upper normal limit; AST and ALT 2.5 times upper normal limit
- Female participants must have a negative pregnancy test unless surgically or naturally not fertile
- Signed informed consent form
You will not qualify if you...
- Prior anti-tumor therapy including PD-1 inhibitors, CTLA-4 antibodies, EGFR therapies, or anti-angiogenic drugs
- History of autoimmune diseases such as myasthenia gravis, lupus, rheumatoid arthritis, inflammatory bowel disease, or multiple sclerosis (some exceptions apply)
- Participation in another interventional clinical trial within 30 days before screening
- History of other cancers except cured basal cell carcinoma
- Serious uncontrolled medical conditions like heart failure, diabetes, hypertension, liver or kidney failure, thyroid or psychiatric disorders
- Known HIV, active hepatitis, or tuberculosis infection
- Major surgery or planned surgery within 30 days before first treatment dose
- Allergic reaction to study drugs or their components
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during and 6 months after study
- Investigator's judgment of unsuitability for participation
- Unwilling or unable to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Affliated Hospital (Xijing Hospital),the First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
J
Jianjun Yang, Professor
CONTACT
S
Shu Wang
CONTACT
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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