Actively Recruiting
CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer
Led by Shanghai Changzheng Hospital · Updated on 2025-03-14
30
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective, single-arm study aims to investigate the efficacy and safety of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS locally advanced rectal cancer patients
CONDITIONS
Official Title
CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed rectal adenocarcinoma with clinical stage cT3+N+M0
- Confirmed pMMR/MSS status by immunohistochemistry and/or genetic testing
- Newly diagnosed or recurrent patients accepted; recurrent patients must not have had chemotherapy, targeted therapy, or immunotherapy within 1 month, or radiotherapy within 1 year
- Measurable disease per RECIST 1.1 and no prior local treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No distant metastasis confirmed by CT, MRI or PET/CT
- Adequate blood counts and organ function based on specified lab tests within 7 days before first dose
- Negative serum pregnancy test for women of childbearing age and agreement to use effective contraception during and 60 days after treatment
- Life expectancy greater than 3 months
- Signed informed consent
You will not qualify if you...
- Prior treatment with anti-PD1, anti-PDL1, anti-PDL2, or anti-CTLA4 antibodies
- Uncontrolled active bleeding from the tumor or intestinal obstruction
- Contraindications to bevacizumab
- Allergic reaction to monoclonal antibodies
- Active or suspected autoimmune disease
- Moderate or greater uncontrolled pleural, pericardial effusion, or ascites
- History of lung diseases such as idiopathic pulmonary fibrosis or pneumonia or active pneumonia on CT
- Major surgery within 4 weeks prior to enrollment without full recovery
- Active bleeding, abnormal coagulation, bleeding tendency, or use of anticoagulants/thrombolytics
- Previous allogeneic stem cell or organ transplantation
- Significant clinical or lab abnormalities affecting safety including infections, diabetes, heart diseases, kidney disease, neuropathy, or other malignancies
- Uncorrected electrolyte disorders
- HIV infection
- Active hepatitis B or C
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Other malignancies within 5 years except certain skin and cervical cancers
- Use of corticosteroids over 10mg/day prednisone equivalent or immunosuppressants within 14 days before enrollment
- Active tuberculosis or recent anti-TB treatment within 1 year
- Active infection or recent antibiotic treatment within 2 weeks prior to therapy except prophylaxis
- Vaccination with anti-infective vaccines within 4 weeks before therapy
- Participation in other clinical trials within 4 weeks prior to therapy
- Any other illness or condition that may increase risk or affect study results or patient compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, China
Actively Recruiting
Research Team
H
Haiyang Zhou, MD
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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