Actively Recruiting
A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2026-01-16
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In a single-center, prospective, phase II study (ClinicalTrials registration number: \[to be filled in\]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy. It is anticipated that 30 subjects with locally advanced rectal cancer will be enrolled between September 2025 and September 2027. This phase II exploratory study targets patients with locally advanced mid-low MSS/pMMR rectal cancer. It employs short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy, aiming to clarify the efficacy and safety of this new combined radiotherapy, chemotherapy, targeted therapy, and immunotherapy approach, while also assessing the rectal/anal preservation rate and quality of life of patients. After neoadjuvant therapy, patients will undergo imaging and endoscopic evaluations to determine subsequent treatment strategies. Radical surgical resection will be performed on patients after neoadjuvant immunotherapy, followed by further analysis of the pathological complete response (pCR) rate. The primary study endpoint is the pCR rate, and secondary study endpoints include the objective response rate, organ preservation rate, 3-year disease-free survival (DFS), 3-year overall survival (OS), incidence of adverse events, and quality of life scores (EORTC QLQ-C30, EORTC QLQ-CR29, Wexner).
CONDITIONS
Official Title
A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years with no gender restrictions
- Diagnosed with mid-low locally advanced rectal adenocarcinoma located 10 cm from the anal verge, clinical stage cT3-4N0/+M0, with lymph nodes confined to the mesorectum
- Histologically confirmed rectal adenocarcinoma with MSS or MSI-L status by genetic testing, or pMMR by immunohistochemistry
- ECOG performance status score of 0-1
- No prior antitumor therapy, immunotherapy, anti-angiogenic therapy, or pelvic radiotherapy before enrollment
- Laboratory tests meeting specific blood counts, coagulation, liver and kidney function criteria
- Desire to preserve the anus and willingness to receive the full neoadjuvant therapy course
- Willing to voluntarily participate, sign informed consent, and comply with scheduled visits and follow-up
You will not qualify if you...
- Current or past history of active malignant tumors other than rectal cancer
- Presence of metastases to other sites on preoperative staging
- Suspicious positive lymph nodes outside the rectal drainage area, such as internal or external iliac lymph nodes
- Need for emergency surgery due to intestinal obstruction, perforation, or hemorrhage
- Severe comorbid conditions with life expectancy 5 years
- Known allergy to any study components
- Use of immunosuppressive or systemic corticosteroid therapy within 30 days before treatment start
- Participation in another investigational drug trial within 30 days before screening
- Factors affecting study results or causing premature termination, including alcoholism, drug abuse, severe diseases, psychiatric disorders, or severe lab abnormalities
- Congenital or acquired immunodeficiency such as HIV infection
- Vulnerable populations including psychiatric disorders, cognitive impairments, critically ill patients, minors, pregnant women, or illiterate individuals
- Other investigator-judged unsuitability for clinical trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
Y
Yifei Pan, Master's Degree in Medicine
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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