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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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