Actively Recruiting
Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer
Led by Sir Run Run Shaw Hospital · Updated on 2025-01-09
32
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, prospective, multicenter phase II clinical trial to evaluate modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for patients with MSS middle and low rectal cancer. A total of 32 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The organ preservation rate, tumor regression grade, long-term prognosis, and adverse effects will also be analyzed.
CONDITIONS
Official Title
Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who strongly wish to preserve the anus and agree to receive neoadjuvant therapy
- Male or female aged 18 to 75 years
- Diagnosed with low rectal cancer within 10 cm from tumor lower edge to anal verge by pelvic MRI and anorectoscopy; clinical stage cT2N+M0 or cT3-4aN0/+M0; lymph nodes limited to mesorectum; negative circumferential resection margin
- Histologically confirmed rectal adenocarcinoma with MSI-L or MSS status or pMMR by immunohistochemistry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No previous anti-tumor therapy, immunotherapy, or pelvic radiation
- Adequate blood, liver, kidney, thyroid, and heart function as defined by specific laboratory values
- Signed informed consent form
You will not qualify if you...
- History of malignant tumors other than rectal cancer
- Presence of distant metastases before enrollment
- Positive internal or external iliac lymph nodes by MRI or CT
- Obstruction, perforation, or bleeding requiring emergency surgery
- Severe other diseases with expected survival of 5 years or less
- Allergy to any therapy components
- Poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma
- Immunosuppressive or systemic hormone therapy for immunosuppression within 1 month before therapy
- Participation in other experimental drug trials within 30 days before screening
- Factors such as alcoholism, drug abuse, serious illnesses requiring combined therapy, severe lab abnormalities
- Congenital or acquired immune deficiency like HIV infection
- Vulnerable groups including mentally ill, cognitively impaired, critically ill, minors, pregnant or lactating women, illiterate
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sir Run Run Shao hospital
Hanzhou, Zhejiang, China, 310012
Actively Recruiting
Research Team
Z
Zhangfa Song, M.D, PH.D
CONTACT
C
Cheng Cai, master
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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