Actively Recruiting
Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)
Led by Hebei Medical University Fourth Hospital · Updated on 2025-08-14
90
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
CONDITIONS
Official Title
Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Pathologic diagnosis of adenocarcinoma of the rectum, confirmed pMMR type
- Clinical stage T3-4NanyM0 or T1-2N+M0 based on AJCC 8th edition
- Primary tumor lower margin below the peritoneal reflex or within 10 cm from the anal verge
- Blood counts: neutrophils 1.5 x 10^9/L, platelets 100 x 10^9/L, hemoglobin 90 g/L
- Liver and kidney function: ALT/AST 2.5 x ULN, total bilirubin 1.5 x ULN, creatinine 1.5 x ULN or creatinine clearance 60 mL/min
- Coagulation: INR 1.5, APTT 1.5 x ULN (if not on anticoagulants)
- Agree to use effective contraception during study and for 6 months after last treatment
- Voluntary written informed consent and commitment to full treatment and follow-up
You will not qualify if you...
- Pathologic types other than adenocarcinoma, such as neuroendocrine or squamous carcinoma
- Previous radiotherapy, chemotherapy, targeted therapy, or immunotherapy for rectal cancer
- Active autoimmune diseases requiring long-term immunosuppression
- Active infections including HIV or hepatitis B/C requiring stabilized treatment
- Severe cardiovascular disease (recent myocardial infarction, unstable angina, uncontrolled hypertension >160/100 mmHg)
- History of other malignancies except certain cured cancers for more than 5 years
- Uncontrolled diabetes (HbA1c > 8%) or abnormal thyroid function requiring treatment
- Severe chronic bowel diseases like Crohn's disease or active ulcerative colitis
- Any condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
Research Team
F
Fengpeng Wu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here