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ACTIVE NOT RECRUITING
NCT05009069
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC). The study consists of a safety run-in phase and a randomization phase. Participants enrolled in the safety run-in phase will receive atezolizumab + tiragolumab following nCRT. Upon determination of the safety of the treatment regimen, the study will be proceed to the randomization phase. Participants will be randomized in a 1:1 ratio to the atezolizumab + tiragolumab arm or atezolizumab arm.

Official title: A Phase II, Randomized, Open Label, Parallel-group Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2022-03-18

Completion Date

2026-11-06

Last Updated

2026-01-22

Healthy Volunteers

No

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.

Locations (5)

Beijing Cancer Hospital

Beijing, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Zhongshan Hospital Fudan University

Shanghai, China

First Hospital of China Medical University

Shenyang, China