Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

Recruiting Phase 2 Interventional Study
Locally Advanced Rectal Cancer Neoadjuvant Therapy
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
138 (estimated)
Sponsor
Fudan University · Other
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About This Trial
SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years, gender not limited 2. Pathologically confirmed rectal adenocarcinoma 3. ≤10 cm from the anus 4. Baseline stage T3-4/N+ 5. No distant metastasis 6. MSI/MMR status MSS/pMMR 7. Karnofsky performance status score ≥70 8. No prior chemotherapy or other anti-cancer …
Contacts

Zhen Zhang, M.D, PH.D

18801735029

zhen_zhang@fudan.edu.cn

CONTACT

Yajie Chen, PH.D

18917239680

16111230008@fudan.edu.cn

CONTACT