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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522120-28-00

Enrollment

Registered

2026-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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

Interventions

DRUGTislelizumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 11, 2026