NCT06840665 MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
| NCT ID | NCT06840665 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Locally Advanced Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2026-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2024-08-13 with a primary completion date of 2026-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06840665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06840665 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06840665 currently recruiting?
Yes, NCT06840665 is actively recruiting participants. Contact the research team at zhen_zhang@fudan.edu.cn for enrollment information.
Where is the NCT06840665 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06840665 clinical trial?
NCT06840665 is sponsored by Fudan University. The trial plans to enroll 46 participants.
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