Actively Recruiting
Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.
Led by brenner baruch · Updated on 2025-07-24
134
Participants Needed
2
Research Sites
262 weeks
Total Duration
On this page
Sponsors
B
brenner baruch
Lead Sponsor
J
Johannes Gutenberg University Mainz
Collaborating Sponsor
AI-Summary
What this Trial Is About
This prospective, multi-center, phase II randomized controlled trial will evaluate the actual benefit of adding immunotherapy with tislelizumab to the currently most effective approach against LARC, namely TNT. In this trial, we will harness several elements that may each potentially contribute to an overall high efficacy, at least in local outcomes: nCRT rather than SCRT, full length (8 cycles of mFOLFOX6) of consolidation chemotherapy, CIMT following nCRT (exploiting the upregulation of the immune response induced by the latter) and tislelizumab (with its theoretical advantage over other CPIs). In line with the changing treatment paradigms in LARC, in which high therapeutic efficacy translates into the possibility to avoid TME, the trial will have a novel primary endpoint of long-term unmaintained cCR, i.e. 3 year TME-free survival.
CONDITIONS
Official Title
Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary locally advanced rectal cancer (tumor 12 cm or less from anal verge) stage T3-4 N0 or TX N+ by MRI and PET-CT
- Planned for total neoadjuvant treatment and considered a surgical candidate
- No prior chemotherapy, immunotherapy, radiotherapy, or surgery for rectal cancer
- No prior pelvic radiotherapy for any reason
- Able to provide tissue samples for diagnosis confirmation and investigational purposes
- Age 18 years or older
- ECOG performance status less than 2
- Laboratory values meeting specific criteria for blood counts, kidney and liver function
- Able to swallow tablets
- Using effective contraception if fertile, during study and for specified periods after treatment
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Women must not be breastfeeding
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Active or history of autoimmune disease except type I diabetes, hypothyroidism, or certain skin disorders not requiring systemic treatment
- History of vasculitis
- Prior organ transplant including bone marrow transplantation
- Peripheral sensory neuropathy greater than grade 1
- Prior treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, PD-L2, CD137, or CTLA-4
- Any active malignancy within 2 years before trial entry except certain treated local cancers
- Serious or uncontrolled medical disorders or active infections increasing study risk or impairing treatment
- Known HIV infection or AIDS
- Known active hepatitis B or C infection or detectable viral loads if previously infected
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Johannes Gutenberg-University Clinic, Mainz, Germany 1.Dept. Medicine, Prof. Peter R. Galle
Mainz, Germany
Not Yet Recruiting
2
Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel
Actively Recruiting
Research Team
B
Baruch Brenner, M.D
CONTACT
A
Ayelet Rosenberg Ayal, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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