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MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

RecruitingPhase 2Ages 18 Years - 75 YearsAllFudan University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-70 years old, male or female 2. Pathologically confirmed rectal adenocarcinoma 3. The distance from anal verge ≤ 10 cm 4. Clinical stage T3-4 and/or N+ 5. No evidence of distance metastases 6. MSI/MMR status: MSS/pMMR 7. Karnofsky score \>=70 8. Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy 9. No chemotherapy or any other anti-tumor therapy prior to enrollment 10. No immunotherapy prior to enrollment 11. With good compliance during the study 12. Signed written informed consent Exclusion Criteria: 1. Known history of other malignancies within 5 years, except cured skin cancer and cervical cancer in situ 2. Pregnancy or breast-feeding women 3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications 4. Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months 5. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy 6. Individuals with autoimmune diseases 7. Individuals with severe uncontrolled recurrent infections,or other severe uncontrolled concomitant diseases 8. Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB \<1.5 times the upper limit of normal; Cr \<1 time the upper limit of normal; Alb ≥30g/L 9. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency 10. Individuals allergic to any drug component of the study
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What it tests

  • PD-1 antibody
  • Oxaliplatin
  • Capecitabine
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Where

1 site
Fudan University Shanghai Cancer Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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