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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Weeks 1-5: 45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
Weeks 1-5: Capecitabine 825 mg/m\^2 orally twice daily (bid) 5 days/week during radiotherapy.
Weeks 1-5: fluorouracil (5-FU) 225 mg/m\^2 intravenously (IV) over 24 hours 5 days/week during radiotherapy.
Weeks 8, 11 and 14: Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle for 3 cycles.
Weeks 8, 11 and 14: Tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 3 cycles.
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
Percentage of Participants With Pathological Complete Response (pCR)
Time frame: At Week 16, Day 1
Percentage of Participants With R0 Resection
Time frame: At Week 16, Day 1
Objective Response Rate (ORR) Before Surgery
Time frame: At Week 16, Day 1
One/Two/Three-year Relapse-free Survival (1/2/3-y RFS) Rate
Time frame: Year 1, Year 2, Year 3
One/Two/Three-year Event-free Survival (1/2/3-y EFS) Rate
Time frame: Year 1, Year 2, Year 3
Percentage of Participants With pCR in Subgroup Population With PD-L1/ PVR/TIGIT Positive Expression
Time frame: At Week 16, Day 1
1/2/3-y Disease-free Survival (DFS) Rate in Subgroup Population With PD-L1/ PVR/TIGIT Positive Expression
Time frame: Year 1, Year 2, Year 3
1/2/3-y EFS Rate in Subgroup Population With PD-L1/ PVR/TIGIT Positive Expression
Time frame: Year 1, Year 2, Year 3
Percentage of Participants With Adverse Events
Time frame: Up to 40 months
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