NCT03127007

Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer

A Phase Ib/II Study to Evaluate Safety and Efficacy of Atezolizumab Combined With Radio-chemotherapy in a Preoperative Setting for Patients With Localized Rectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Grand Hôpital de Charleroi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy. The phase II part of the study aims to explore efficacy of atezolizumab in combination with the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.

Conditions

• Rectal Neoplasms

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV.
DRUG	5-FU based radio-chemotherapy	IV protracted 5-FU given at 225mg/m2 over 24h 5 days/week for 5 weeks associated to radiotherapy.

Timeline

• Start date: 2017-04-27
• Primary completion: 2024-02-22
• Completion: 2024-10-15
• First posted: 2017-04-25
• Last updated: 2025-01-22

Locations

5 sites across 1 country: Belgium