Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low 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
186 (estimated)
Sponsor
Beijing Friendship Hospital · Other
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About This Trial
This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequent…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * aged 18\~75 * ECOG score 0\~2 * biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge * no distant metastasis, staged II/III (T4b excluded) by MRI * maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MRI (i.e. a "measurable lesi…
Contacts

Zhongtao Zhang, M.D.

+8613801060364

zhangzht@ccmu.edu.cn

CONTACT