Total Neoadjuvant Treatment with or without Tislelizumab for Locally Advanced Rectal Cancer: An Open-label Randomized Controlled Phase II Study (The TOTAL Trial)

2025-522120-28-00 · tracked via the Priya Life Science EU tracker

Sponsor

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Rabin Medical Center

Sponsor type

Hospital/Clinic/Other health care facility, Hospital/Clinic/Other health care facility

Therapeutic area

Neoplasms

Decision date

10/02/2026

Enrollment target

Sites

Germany

Condition studied

Locally Advanced Rectal Cancer (LARC) stage II (T3-4N0M0) or stage III (TxN1-2M0)

Investigational medicinal product(s)

Tislelizumab

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

The primary endpoint is the 3-year TME-free survival rates (intention to treat, ITT)

Endpoint detail

3-year TME-free survival (CPS≥1%), cCR, DFS, PFS, OS rates, safety and toxicity profile, patient-reported functional outcomes and QoL (quality of life) with EORTC QLQ-C30 and CR-29

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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