Actively Recruiting
Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-11-24
20
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are: Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs. Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.
CONDITIONS
Official Title
Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent
- Aged 18 to 75 years
- Pathologically confirmed rectal squamous cell carcinoma
- Imaging confirms no distant metastases
- Adequate blood counts and liver and kidney function within 14 days before treatment:
- White blood cell count at least 3.0 x10^9/L or neutrophils at least 1.5 x10^9/L
- Hemoglobin at least 80 g/L
- Platelets at least 100 x10^9/L
- Liver enzymes (AST/ALT) less than 3 times the upper normal limit
- Total bilirubin less than 1.5 times the upper normal limit
- Creatinine less than 1.5 times the upper normal limit
- ECOG performance status score between 0 and 2
- No history of other malignant tumors in the past
You will not qualify if you...
- Previously treated with chemotherapy, radiotherapy, or complete surgery for rectal squamous cell carcinoma
- Presence of distant metastases confirmed by whole-body CT, MRI, or PET-CT
- Current or past other active cancers except those cured and disease-free for more than 3 years or carcinoma in situ treated adequately
- Major surgery or severe trauma within past 4 weeks with unhealed incision
- Active coronary artery disease, severe or unstable angina, or recent myocardial infarction within 12 months
- Thrombotic or embolic events like stroke, pulmonary embolism, or deep vein thrombosis within past 6 months
- Congestive heart failure classified as New York Heart Association Class II or higher
- Prior use of any investigational drug
- Pregnant or breastfeeding women
- Any unstable medical condition affecting safety or study compliance
- Investigator judged unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jun Huang, MD
CONTACT
F
Fang He, 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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