Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer

Recruiting Phase 2 Interventional Study
Rectal Cancer, Adenocarcinoma Neoadjuvant Therapy Immunotherapy Probio-M9 Tislelizumab Randomized
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 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Seventh Medical Center of PLA General Hospital · Other
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About This Trial
This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+plac…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * ECOG performance status 0-2 * Biopsy-proven rectal adenocarcinoma * Distal tumor margin within 10 cm of the anal verge * No distant metastasis * Clinical stage II or III based on MRI (T4b excluded) * Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or M…
Contacts

Junfeng Du, PhD

+86-15810908850

dujunfeng@301hospital.com.cn

CONTACT