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

Recruiting Phase 2 Interventional Study
Locally Advanced Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
Fudan University · Other
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About This Trial
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 …
Trial Locations
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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…
Contacts

Zhen Zhang, MD

+86 18017312217

zhen_zhang@fudan.edu.cn

CONTACT