Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer

Recruiting Phase 3 Interventional Study
Rectal Cancer pMMR (Microsatellite Stable Rectal Cancer)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. 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 3
Study type
Interventional
Purpose
Treatment
Participants needed
556 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial
This is a multicenter, phase III, randomized controlled trial. Eligible patients with pMMR/MSS locally advanced rectal cancer will be randomized in a 1:1 ratio to either the experimental group or the control group using stratified randomization, with mesorectal fascia (MRF) status as the stratification factor. Patients in the experimental group will receive four cycles of CAPOX plus pucotenlimab.…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 75 years. 2. Histologically confirmed rectal adenocarcinoma. 3. The lower edge of the tumor is ≤12 cm from the anal verge. 4. Clinical stage of cT3-4aN0M0 or cT1-4aN+M0 at initial diagnosis. Pre-treatment staging methods: Required: chest and abdominal CT and…
Contacts

Kai Han, M.D

+86-18602042643

hankai@sysucc.org.cn

CONTACT