NCT05009069View on ClinicalTrials.gov

A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 18, 2022

Primary Completion Date

November 21, 2023

Study Completion Date

November 6, 2026

Conditions
Rectal NeoplasmsRectal Cancer
Interventions
RADIATION

Radiotherapy

Weeks 1-5: 45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.

DRUG

Capecitabine

Weeks 1-5: Capecitabine 825 mg/m\^2 orally twice daily (bid) 5 days/week during radiotherapy.

DRUG

Fluorouracil

Weeks 1-5: fluorouracil (5-FU) 225 mg/m\^2 intravenously (IV) over 24 hours 5 days/week during radiotherapy.

DRUG

Atezolizumab

Weeks 8, 11 and 14: Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle for 3 cycles.

DRUG

Tiragolumab

Weeks 8, 11 and 14: Tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 3 cycles.

Trial Locations (5)

100142

Beijing Cancer Hospital, Beijing

110001

First Hospital of China Medical University, Shenyang

200032

Zhongshan Hospital Fudan University, Shanghai

310009

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

510655

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY