Actively Recruiting
MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
Led by Fudan University · Updated on 2025-02-21
46
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.
CONDITIONS
Official Title
MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years old, male or female
- Pathologically confirmed rectal adenocarcinoma
- Tumor located within 10 cm from the anal verge
- Clinical stage T3-4 and/or lymph node positive
- No distant metastases
- Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status
- Karnofsky performance score of 70 or higher
- Adequate organ function without contraindications to surgery, radiochemotherapy, or immunotherapy
- No prior chemotherapy or anti-tumor therapy before enrollment
- No prior immunotherapy before enrollment
- Willing and able to comply with study procedures
- Signed informed consent
You will not qualify if you...
- History of other cancers within 5 years except cured skin cancer and cervical cancer in situ
- Pregnancy or breastfeeding
- History of uncontrolled epilepsy, central nervous system disease, or severe psychiatric disorders affecting consent or medication adherence
- Serious heart disease including symptomatic coronary artery disease, NYHA class II or worse heart failure, severe arrhythmia requiring treatment, or recent myocardial infarction within 12 months
- History of organ transplantation requiring immunosuppressive or long-term hormone therapy
- Autoimmune diseases
- Severe uncontrolled recurrent infections or other serious uncontrolled diseases
- Blood and chemistry values outside specified limits (e.g., hemoglobin below 90g/L, neutrophils below 1.5×10^9/L, platelets below 100×10^9/L, liver enzymes above 2.5 times normal, bilirubin above 1.5 times normal, creatinine above normal, albumin below 30g/L)
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- Allergy to any component of the study drugs
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Z
Zhen Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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