Actively Recruiting
Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
Led by Sun Yat-sen University · Updated on 2026-04-20
156
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.
CONDITIONS
Official Title
Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Histologically confirmed colorectal adenocarcinoma
- Liver metastases confirmed by imaging or pathology, with 5 or fewer lesions
- RAS and BRAF wild-type confirmed by genetic testing or immunohistochemistry
- pMMR/MSS status confirmed
- No extrahepatic metastases confirmed by CT, MRI, or PET/CT if needed
- Primary colorectal tumor has been or can be completely removed by surgery
- Liver metastases are surgically removable or treatable with radiofrequency ablation or SBRT, with expected no evidence of disease after surgery
- No prior anti-tumor treatment for liver metastases except surgery on the primary tumor
- Normal blood cell counts (platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L)
- Liver function within defined limits (bilirubin ≤1.5× ULN, transaminases ≤5× ULN, alkaline phosphatase ≤2.5× ULN, no ascites, normal coagulation, albumin ≥35 g/L)
- Liver function classified as Child-Pugh grade A
- Serum creatinine below upper normal limit or creatinine clearance >50 ml/min
- ECOG performance status 0-1
- Expected survival longer than 3 months
- Signed informed consent and willingness to be followed until death, study end, or termination
You will not qualify if you...
- Presence of colorectal cancer with distant extrahepatic metastases
- Prior chemotherapy, targeted therapy, intervention, or immunotherapy for liver metastases
- No plan for surgical removal of liver metastases
- Received oxaliplatin-based adjuvant chemotherapy within the past year
- Remaining toxicity from previous chemotherapy except hair loss, including peripheral neuropathy grade 2 or higher
- Use of immunosuppressive drugs within one week before starting study treatment, except certain corticosteroids
- Interstitial lung disease requiring corticosteroids
- Active autoimmune disease requiring treatment or history within past 2 years, except controlled conditions like vitiligo, psoriasis, alopecia, Graves' disease without recent systemic treatment, hypothyroidism on thyroid hormone, or type I diabetes on insulin
- History of primary immunodeficiency
- Active tuberculosis
- History of organ or stem cell transplantation
- Allergy to monoclonal antibodies or chemotherapy drugs used in the study
- Bleeding disorders or coagulation problems
- Significant intestinal obstruction symptoms
- Hypertensive crisis or encephalopathy
- Severe uncontrolled infections or diabetes
- Severe cardiovascular diseases including recent stroke or heart attack, uncontrolled hypertension, unstable angina, heart failure NYHA 2-4, or arrhythmias needing medication
- Central nervous system diseases such as brain tumors, uncontrolled epilepsy, brain metastases, or stroke history
- Other cancers diagnosed within past 5 years except certain skin or cervical cancers
- Participation in other investigational drug trials within 28 days before this study
- Pregnant or breastfeeding women, or women of childbearing potential not using effective non-hormonal contraception, or men unwilling to comply with study contraception requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yuhong Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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