Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.

PHASE2RecruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

July 23, 2025

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2030

Conditions
Locally Advanced Rectal Cancer (LARC)
Interventions
DRUG

Tislelizumab

During ChemoImmunotherapy: Patients in the investigational arm will receive 8 cycles of tislelizumab 150 mg IV on Day 1, followed by mFOLFOX6 (Q2W).

DRUG

Total neoadjuvant therapy (TNT)

Patients will be treated with 6 weeks of capecitabine-based CRT followed 4 weeks later by 16 weeks of chemotherapy with mFOLFOX6, Q2W.

Trial Locations (2)

Unknown

NOT_YET_RECRUITING

Johannes Gutenberg-University Clinic, Mainz, Germany 1.Dept. Medicine, Prof. Peter R. Galle, Mainz

RECRUITING

Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, Petah Tikva

All Listed Sponsors
collaborator

Johannes Gutenberg University Mainz

OTHER

lead

brenner baruch

OTHER

NCT06940388 - Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer. | Biotech Hunter | Biotech Hunter