Actively Recruiting
CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer
Led by Shanghai Changzheng Hospital · Updated on 2025-03-18
15
Participants Needed
1
Research Sites
212 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 CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer
CONDITIONS
Official Title
CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary colorectal cancer treated with radical surgery and confirmed adenocarcinoma with R0 resection
- Postoperative adjuvant chemotherapy with Xelox or other first-line standard regimens
- Clinically diagnosed with locally recurrent colorectal adenocarcinoma based on imaging and histology
- No treatment including chemotherapy, targeted therapy, immunotherapy, or radiotherapy within the past month
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No distant metastasis confirmed by CT, MRI, or PET/CT
- Adequate hematologic and organ function based on recent laboratory tests
- Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during treatment and for 60 days after
- Life expectancy greater than 3 months
- Signed and written informed consent
You will not qualify if you...
- Previous treatment with anti-PD1, anti-PDL1, anti-PDL2, or anti-CTLA4 antibodies
- Intestinal obstruction or uncontrollable active bleeding requiring urgent treatment
- Contraindications to Oxaliplatin, Capecitabine, Bevacizumab, or Tislelizumab
- Hypersensitivity to monoclonal antibodies
- Active autoimmune diseases
- Uncontrolled pleural, pericardial effusion, or ascites
- History of certain lung diseases or active pneumonia
- Major surgery within 4 weeks before enrollment without full recovery
- Active bleeding, abnormal coagulation, or use of anticoagulant therapy
- Previous allogeneic stem cell or organ transplantation
- Significant clinical or laboratory abnormalities affecting safety
- Uncorrected electrolyte disturbances
- HIV infection
- Active hepatitis B or C
- Pregnancy or lactation without contraception
- Other malignancies within 5 years except certain skin and cervical cancers
- Use of corticosteroids or immunosuppressants within 14 days before enrollment
- Active tuberculosis or recent anti-TB treatment
- Active infection or recent antibiotic treatment except prophylaxis
- Recent vaccination with anti-infective vaccines within 4 weeks
- Participation in other clinical trials within 4 weeks
- Any other disease or condition that may affect safety, study reliability, or compliance
AI-Screening
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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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