Actively Recruiting
Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer
Led by Jinhua Central Hospital · Updated on 2026-04-24
37
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.
CONDITIONS
Official Title
Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to preserve the anus and receive neoadjuvant therapy
- Male or female aged 18 to 75 years
- Diagnosed with low rectal cancer within 10 cm from tumor to anal verge by MRI and anorectoscopy, clinical stage cT2N+M0 or cT3-4N0/+M0 with lymph nodes limited to mesorectum
- Histologically confirmed rectal adenocarcinoma with MSI-L or MSS status or proficient mismatch repair by immunohistochemistry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No previous anti-tumor treatment, immunotherapy, or pelvic radiation
- Adequate blood counts and organ function as specified
- Signed informed consent form
You will not qualify if you...
- Previous 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 concomitant diseases with expected survival of 5 years or less
- Allergy to any components of the therapy
- Poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma
- Immunosuppressive or systemic hormone therapy within 1 month before treatment start
- Participation in other experimental drug trials within 30 days before screening
- Alcoholism, drug abuse, psychiatric disorders requiring combination therapy, or severe lab abnormalities
- Congenital or acquired immune deficiency such as HIV
- 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
Zhejiang University Affiliated Jinhua Hospital
Jinhua, Zhejiang, China, 0579
Actively Recruiting
Research Team
J
jinlin du, master
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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